OBAGI SKINTRINSIQ BRIGHTENING PROTOCOL- homosalate, octisalate, and zinc oxide kit

Obagi Skintrinsiq Brightening Protocol by

Drug Labeling and Warnings

Obagi Skintrinsiq Brightening Protocol by is a Otc medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, G.S.COSMECEUTICAL USA, INC., Denison Pharmaceuticals, LLC, Swiss-American CDMO, LLC, TENCO ASSEMBLIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Obagi® Sun Shield Matte Broad Spectrum SPF 50 Sunscreen

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Homosalate 10%	Sunscreen
Octisalate 5%	Sunscreen
Zinc Oxide 16.5%	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

Stop use and ask a doctor if rash occurs

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

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
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• 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 value 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Other information

• store at controlled room temperature: 15°–25°C (59°–77°F)
• protect this product from excessive heat and direct sun

Inactive ingredients

Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone

Questions or comments?

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

SKINTRINSIQ™

BRIGHTENING
PROTOCOL KIT

INCLUDES:

• 60 Tips
• Obagi Nu-Derm® Gentle Cleanser, 2 FL. OZ.
• Obagi Nu-Derm® Toner, 2 FL. OZ.
• Obagi Nu-Derm® Clear Fx, 2 FL. OZ.
• Obagi Hydrate® Facial Moisturizer, 1.7 OZ.
• Obagi Sun Shield™ Matte Broad Spectrum SPF 50 Sunscreen, 3 OZ.

OBAGI®

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

OBAGI®
MEDICAL

Sun Shield

MATTE

Broad
Spectrum
SPF 50

Sunscreen
Lotion

Non-Comedogenic
Dermatologist Tested

Net wt. 3 oz (85 g)

INGREDIENTS AND APPEARANCE

OBAGI SKINTRINSIQ BRIGHTENING PROTOCOL 
homosalate, octisalate, and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-905

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-905-05	1 in 1 BOX	08/01/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	60 mL
Part 2	1 BOTTLE, PLASTIC	59 mL
Part 3	1 BOTTLE, PLASTIC	57 g
Part 4	1 BOTTLE, PUMP	48 g
Part 5	1 TUBE	85 g

Part 1 of 5

OBAGI NU-DERM GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] gel

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	APRICOT KERNEL OIL (UNII: 54JB35T06A)
INGR	BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	GLYCERETH-7 (UNII: 3D2Y91QZ2H)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	OLEYL LACTATE (UNII: B3AWW0N3GM)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	SAGE (UNII: 065C5D077J)
INGR	SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
INGR	SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/01/2021

Part 2 of 5

OBAGI NU-DERM TONER 
face and neck (excluding shaving preparations), leave-on [skin care preparations (creams, lotions, powder, and sprays)] liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
INGR	CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
INGR	DMDM HYDANTOIN (UNII: BYR0546TOW)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	POLYSORBATE 80 (UNII: 6OZP39ZG8H)
INGR	POTASSIUM ALUM (UNII: 1L24V9R23S)
INGR	SAGE (UNII: 065C5D077J)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/01/2021

Part 3 of 5

OBAGI NU-DERM CLEAR FX 
face and neck (excluding shaving preparations), leave-on [skin care preparations (creams, lotions, powder, and sprays)] lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ARBUTIN (UNII: C5INA23HXF)
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)
INGR	BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	SODIUM LAURYL SULFATE (UNII: 368GB5141J)
INGR	SODIUM METABISULFITE (UNII: 4VON5FNS3C)
INGR	STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/01/2021

Part 4 of 5

OBAGI HYDRATE FACIAL MOISTURIZER 
moisturizing [skin care preparations (creams, lotions, powder, and sprays)] lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	TARA SPINOSA RESIN (UNII: WL3883U2PO)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	LAURETH-12 (UNII: OAH19558U1)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SACCHARIDE ISOMERATE (UNII: W8K377W98I)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
INGR	SOY STEROL (UNII: PL360EPO9J)
INGR	SOYBEAN (UNII: L7HT8F1ZOD)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		48 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/01/2021

Part 5 of 5

SUN SHIELD BROAD SPECTRUM SPF 50 MATTE  SUNSCREEN
homosalate, octisalate, and zinc oxide lotion

Product Information
Item Code (Source)	NDC: 62032-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	165 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
C15-19 ALKANE (UNII: CI87N1IM01)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-140-09	1 in 1 CARTON
1		85 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 Drug	M020	08/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/01/2021

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
G.S.COSMECEUTICAL USA, INC.		017014734	manufacture(62032-905)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(62032-905)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(62032-905)

Establishment
Name	Address	ID/FEI	Business Operations
TENCO ASSEMBLIES, INC		075535609	pack(62032-905)