CLE DE PEAU BEAUTE RADIANT FOUNDATION N M O30- octinoxate and titanium dioxide cream CLE DE PEAU BEAUTE RADIANT FOUNDATION N M O90- octinoxate and titanium dioxide cream CLE DE PEAU BEAUTE RADIANT FOUNDATION N M O20- octinoxate and titanium dioxide cream CLE DE PEAU BEAUTE RADIANT FOUNDATION N M O70 (octinoxate and titanium dioxide) creamCLE DE PEAU BEAUTE RADIANT FOUNDATION N M B50- octinoxate and titanium dioxide cream CLE DE PEAU BEAUTE RADIANT FOUNDATION N M B40- octinoxate and titanium dioxide cream CLE DE PEAU BEAUTE RADIANT FOUNDATION N M BF50- octinoxate and titanium dioxide cream CLE DE PEAU BEAUTE RADIANT FOUNDATION N M O40- octinoxate and titanium dioxide cream

cle de peau BEAUTE RADIANT FOUNDATION N M by

Drug Labeling and Warnings

cle de peau BEAUTE RADIANT FOUNDATION N M by is a Otc medication manufactured, distributed, or labeled by Shiseido Americas Corporation, Shiseido America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

PURPOSE

• Active Ingredients: Purpose
• Octinoxate 4.4%: Sunscreen
• Titanium Dioxide 1.2%: Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating.
• reapply at least every 2 hours.
• Sun Protection Measures. Spending time in the sum increases your risk of skin cancer and early skin aging. To decrease this risk, regularly  use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

       limit time in the sun, especially from 10 a.m. - 2 p.m.

       wear long-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

WATER･DIMETHICONE･DIPHENYLSILOXY PHENYL TRIMETHICONE･DIPROPYLENE GLYCOL･GLYCERIN･BUTYLENE GLYCOL･PEG-10 DIMETHICONE･PEG-20･LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･PEG-6･PEG-32･DISTEARDIMONIUM HECTORITE･BARIUM SULFATE･DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER･DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER･HYDROGENATED POLYISOBUTENE･TREHALOSE･ARGANIA SPINOSA KERNEL OIL･GLYCINE･PEG/PPG-14/7 DIMETHYL ETHER･POTENTILLA ERECTA ROOT EXTRACT･TRIMETHYLSILOXYSILICATE･ROSA ROXBURGHII FRUIT EXTRACT･ANGELICA ACUTILOBA ROOT EXTRACT･HYDROLYZED CONCHIOLIN PROTEIN･HYDROLYZED SILK･PERILLA OCYMOIDES LEAF EXTRACT･SORBITAN SESQUIISOSTEARATE･DIISOSTEARYL MALATE･BEHENIC ACID･SYNTHETIC FLUORPHLOGOPITE･ALUMINUM HYDROXIDE･DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER･TRISODIUM EDTA･TALC･TRIETHOXYCAPRYLYLSILANE･POLYSILICONE-2･STEARIC ACID･TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE･HYDROGEN DIMETHICONE･BHT･SILICA･THEANINE･TOCOPHEROL･MICA･POLYMETHYLSILSESQUIOXANE･METHYLPARABEN･ETHYLPARABEN･FRAGRANCE･IRON OXIDES･TITANIUM DIOXIDE･

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or Comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - I10

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - B10

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - B20

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - B30

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - B40

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - B50

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - B60

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - B70

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - B80

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - B90

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - B100

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - BF10

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - BF50

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - BF60

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - O10

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - O20

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - O30

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - O40

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - O50

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - O60

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - O70

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - O80

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - O90

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

PRINCIPAL DISPLAY PANEL - 21mL Tube Carton - O100

clé de peau

BEAUTÉ

RADIANT CREAM

FOUNDATION n

BROAD SPECTRUM

SPF 25

SUNSCREEN

21mL NET WT. .88 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  O30
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-976
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-976-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  O90
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-982
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-982-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  O20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-975
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-975-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  O70
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-980
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-980-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  B20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-985
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-32 (UNII: 1212Z7S33A)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-985-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  BF60
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-996
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-996-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  B80
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-991
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-991-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  B10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-984
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-32 (UNII: 1212Z7S33A)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-984-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  B60
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-989
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-989-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M   I10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-973
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-973-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  B90
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-992
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-992-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  O50
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-978
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-978-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  O60
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-979
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-979-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  B100
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-993
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-993-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  BF10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-994
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-994-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  O80
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-981
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-981-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  O100
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-983
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-983-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  B30
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-986
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-986-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  B70
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-990
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-990-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  O10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-974
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-974-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  B50
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-988
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-988-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  B40
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-987
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-987-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  BF50
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-995
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PEG-32 (UNII: 1212Z7S33A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-995-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

CLE DE PEAU BEAUTE RADIANT FOUNDATION N M  O40
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-977
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.06 g  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.29 g  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PEG-20 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TREHALOSE (UNII: B8WCK70T7I)
PERILLA OCYMOIDES SEED OIL (UNII: 322MS57V7Z)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BEHENIC ACID (UNII: H390488X0A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
TRISODIUM EDTA (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-977-60	1 in 1 BOX	12/02/2024
1		21 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/02/2024

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	analysis(58411-973, 58411-974, 58411-975, 58411-976, 58411-977, 58411-978, 58411-979, 58411-980, 58411-981, 58411-982, 58411-983, 58411-984, 58411-985, 58411-986, 58411-987, 58411-988, 58411-989, 58411-990, 58411-991, 58411-992, 58411-993, 58411-994, 58411-995, 58411-996) , manufacture(58411-973, 58411-974, 58411-975, 58411-976, 58411-977, 58411-978, 58411-979, 58411-980, 58411-981, 58411-982, 58411-983, 58411-984, 58411-985, 58411-986, 58411-987, 58411-988, 58411-989, 58411-990, 58411-991, 58411-992, 58411-993, 58411-994, 58411-995, 58411-996)