BEAUTY BALM/TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30 BB CRM FAIR- octinoxate, octisalate, and titanium dioxide cream BEAUTY BALM/TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30 BB CRM MED- octinoxate, octisalate, and titanium dioxide cream BEAUTY BALM/TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30 BB CRM MED/DEEP- octinoxate, octisalate, and titanium dioxide cream

BEAUTY BALM/TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30 by

Drug Labeling and Warnings

BEAUTY BALM/TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30 by is a Otc medication manufactured, distributed, or labeled by Bluemercury. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 7.5%	sunscreen
Octisalate 5%	sunscreen
Titanium Dioxide 15%	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 on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Sun Protection Measures. Spending time in the sun 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 measure including:
  • Limit time in the sun, especially from 10am - 2pm.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months of age: Ask a doctor.

Inactive ingredients

Water, Methyl Trimethicone, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Propylene Glycol Dicaprylate/Dicaprate, Tocopherol, Lycium Barbarum Fruit Extract, Pyrus Malus (Apple) Seed Extract, Bulnesia Sarmientoi Wood Oil, Brassica Campestris (Rapeseed) Sterols, Cananga Odorata Flower Oil, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Fruit Oil, Juniperus Mexicana Oil, Beeswax, Dextrin Palmitate, Lysine, Glycerin, Squalane, Magnesium Chloride, Potassium Chloride, Zinc Chloride, Sodium Chloride, Xanthan Gum, Potassium Sorbate, Sodium Hyaluronate, Sodium Dehydroacetate, Hexylene Glycol, Caprylyl Glycol, Sodium Benzoate, Polyethylene, Trimethylsiloxysilicate, Hexyldecanol, Boron Nitride, Triethoxycaprylylsilane, Disteardimonium Hectorite, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Palmitoyl Hexapeptide-14, Sorbitan Oleate, Ethoxydiglycol, Phenoxyethanol, Disodium EDTA, Fragrance | May Contain Titanium Dioxide, Iron Oxides

Other Information

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

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton - BB CRM FAIR

BB

lune+aster®
BEAUTY
BALM
/TINTED
MOISTURIZER
BROAD SPECTRUM
SUNSCREEN
SPF 30

Breathable BB cream/
tinted moisturizer
protects and evens skin
tone with vitamin E,
goji berry and apple
seed extract

protect+go

• light coverage | all skin types

DERMATOLOGIST TESTED
NO ANIMAL TESTING | GLUTEN FREE
PARABEN & PHTHALATE FREE

50 g e 1.7 OZ

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton - BB CRM MED

BB

lune+aster®
BEAUTY
BALM
/TINTED
MOISTURIZER
BROAD SPECTRUM
SUNSCREEN
SPF 30

Breathable BB cream/
tinted moisturizer
protects and evens skin
tone with vitamin E,
goji berry and apple
seed extract

protect+go

• light coverage | all skin types

DERMATOLOGIST TESTED
NO ANIMAL TESTING | GLUTEN FREE
PARABEN & PHTHALATE FREE

50 g e 1.7 OZ

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton - BB CRM MED/DEEP

BB

lune+aster®
BEAUTY
BALM
/TINTED
MOISTURIZER
BROAD SPECTRUM
SUNSCREEN
SPF 30

Breathable BB cream/
tinted moisturizer
protects and evens skin
tone with vitamin E,
goji berry and apple
seed extract

protect+go

• light coverage | all skin types

DERMATOLOGIST TESTED
NO ANIMAL TESTING | GLUTEN FREE
PARABEN & PHTHALATE FREE

50 g e 1.7 OZ

INGREDIENTS AND APPEARANCE

BEAUTY BALM/TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30   BB CRM FAIR
octinoxate, octisalate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72203-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methyl Trimethicone (UNII: S73ZQI0GXM)
Butylene Glycol (UNII: 3XUS85K0RA)
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)
Dimethicone (UNII: 92RU3N3Y1O)
Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)
Tocopherol (UNII: R0ZB2556P8)
Apple (UNII: B423VGH5S9)
Bulnesia Sarmientoi Wood Oil (UNII: 81H0L6W02F)
Rapeseed Sterol (UNII: B46B6DD20U)
Cananga Oil (UNII: 8YOY78GNNX)
Orange Oil (UNII: AKN3KSD11B)
Citrus X Limon Fruit Oil (UNII: 0HNC1J1YED)
Juniperus Deppeana Wood Oil (UNII: 4739QA5686)
Yellow Wax (UNII: 2ZA36H0S2V)
Dextrin Palmitate (Corn; 20000 mw) (UNII: 89B2BSF9I3)
Lysine (UNII: K3Z4F929H6)
Glycerin (UNII: PDC6A3C0OX)
Squalane (UNII: GW89575KF9)
Magnesium Chloride (UNII: 02F3473H9O)
Potassium Chloride (UNII: 660YQ98I10)
Zinc Chloride (UNII: 86Q357L16B)
Sodium Chloride (UNII: 451W47IQ8X)
Xanthan Gum (UNII: TTV12P4NEE)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Sodium Dehydroacetate (UNII: 8W46YN971G)
Hexylene Glycol (UNII: KEH0A3F75J)
Caprylyl Glycol (UNII: 00YIU5438U)
Sodium Benzoate (UNII: OJ245FE5EU)
High Density Polyethylene (UNII: UG00KM4WR7)
Hexyldecanol (UNII: 151Z7P1317)
Boron Nitride (UNII: 2U4T60A6YD)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Disteardimonium Hectorite (UNII: X687XDK09L)
Sorbitan Monooleate (UNII: 06XEA2VD56)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Phenoxyethanol (UNII: HIE492ZZ3T)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72203-002-01	1 in 1 CARTON	08/20/2015
1		50 g 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 FINAL	part352	08/20/2015

BEAUTY BALM/TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30   BB CRM MED
octinoxate, octisalate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72203-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methyl Trimethicone (UNII: S73ZQI0GXM)
Butylene Glycol (UNII: 3XUS85K0RA)
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)
Dimethicone (UNII: 92RU3N3Y1O)
Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)
Tocopherol (UNII: R0ZB2556P8)
Apple (UNII: B423VGH5S9)
Bulnesia Sarmientoi Wood Oil (UNII: 81H0L6W02F)
Rapeseed Sterol (UNII: B46B6DD20U)
Cananga Oil (UNII: 8YOY78GNNX)
Orange Oil (UNII: AKN3KSD11B)
Citrus X Limon Fruit Oil (UNII: 0HNC1J1YED)
Juniperus Deppeana Wood Oil (UNII: 4739QA5686)
Yellow Wax (UNII: 2ZA36H0S2V)
Dextrin Palmitate (Corn; 20000 mw) (UNII: 89B2BSF9I3)
Lysine (UNII: K3Z4F929H6)
Glycerin (UNII: PDC6A3C0OX)
Squalane (UNII: GW89575KF9)
Magnesium Chloride (UNII: 02F3473H9O)
Potassium Chloride (UNII: 660YQ98I10)
Zinc Chloride (UNII: 86Q357L16B)
Sodium Chloride (UNII: 451W47IQ8X)
Xanthan Gum (UNII: TTV12P4NEE)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Sodium Dehydroacetate (UNII: 8W46YN971G)
Hexylene Glycol (UNII: KEH0A3F75J)
Caprylyl Glycol (UNII: 00YIU5438U)
Sodium Benzoate (UNII: OJ245FE5EU)
High Density Polyethylene (UNII: UG00KM4WR7)
Hexyldecanol (UNII: 151Z7P1317)
Boron Nitride (UNII: 2U4T60A6YD)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Disteardimonium Hectorite (UNII: X687XDK09L)
Sorbitan Monooleate (UNII: 06XEA2VD56)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Phenoxyethanol (UNII: HIE492ZZ3T)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72203-003-01	1 in 1 CARTON	08/20/2015
1		50 g 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 FINAL	part352	08/20/2015

BEAUTY BALM/TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30   BB CRM MED/DEEP
octinoxate, octisalate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72203-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methyl Trimethicone (UNII: S73ZQI0GXM)
Butylene Glycol (UNII: 3XUS85K0RA)
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)
Dimethicone (UNII: 92RU3N3Y1O)
Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)
Tocopherol (UNII: R0ZB2556P8)
Apple (UNII: B423VGH5S9)
Bulnesia Sarmientoi Wood Oil (UNII: 81H0L6W02F)
Rapeseed Sterol (UNII: B46B6DD20U)
Cananga Oil (UNII: 8YOY78GNNX)
Orange Oil (UNII: AKN3KSD11B)
Citrus X Limon Fruit Oil (UNII: 0HNC1J1YED)
Juniperus Deppeana Wood Oil (UNII: 4739QA5686)
Yellow Wax (UNII: 2ZA36H0S2V)
Dextrin Palmitate (Corn; 20000 mw) (UNII: 89B2BSF9I3)
Lysine (UNII: K3Z4F929H6)
Glycerin (UNII: PDC6A3C0OX)
Squalane (UNII: GW89575KF9)
Magnesium Chloride (UNII: 02F3473H9O)
Potassium Chloride (UNII: 660YQ98I10)
Zinc Chloride (UNII: 86Q357L16B)
Sodium Chloride (UNII: 451W47IQ8X)
Xanthan Gum (UNII: TTV12P4NEE)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Sodium Dehydroacetate (UNII: 8W46YN971G)
Hexylene Glycol (UNII: KEH0A3F75J)
Caprylyl Glycol (UNII: 00YIU5438U)
Sodium Benzoate (UNII: OJ245FE5EU)
High Density Polyethylene (UNII: UG00KM4WR7)
Hexyldecanol (UNII: 151Z7P1317)
Boron Nitride (UNII: 2U4T60A6YD)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Disteardimonium Hectorite (UNII: X687XDK09L)
Sorbitan Monooleate (UNII: 06XEA2VD56)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Phenoxyethanol (UNII: HIE492ZZ3T)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72203-004-01	1 in 1 CARTON	08/20/2015
1		50 g 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 FINAL	part352	08/20/2015

Labeler - Bluemercury (097435361)