OBAGI SKINTRINSIQ ANTIOXIDANT PROTOCOL- avobenzone, homosalate, octisalate. octocrylene, and oxybenzone kit

Obagi Skintrinsiq Antioxidant Protocol by

Drug Labeling and Warnings

Obagi Skintrinsiq Antioxidant 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 ® Professional-C™ Suncare SPF 30

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3%	Sunscreen
Homosalate 8%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 2.79%	Sunscreen
Oxybenzone 3%	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. If product gets into 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
• 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°C–25°C (59°F–77°F)
• protect this product from excessive heat and direct sun

Inactive ingredients

ascorbic acid, citrus grandis (grapefruit) peel extract, dimethicone, dimethicone crosspolymer, fragrance, octoxynol-9

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™

ANTIOXIDANT 10%
PROTOCOL KIT

INCLUDES:

• 60 Tips
• Obagi Nu-Derm ® Gentle Cleanser, 2 FL. OZ.
• Obagi Nu-Derm ® Toner, 2 FL. OZ.
• Obagi Professional-C ® Serum 10%, 1 FL. OZ.
• Obagi Professional-C ® Peptide Complex, 1 FL. OZ.
• Obagi Professional-C ® Suncare SPF 30, 1.7 OZ.

OBAGI ®

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

OBAGI ®
MEDICAL

Professional-C™
SUNCARE

BROAD SPECTRUM
SPF 30

SUNSCREEN

Net wt. 1.7 oz. (48 g)

INGREDIENTS AND APPEARANCE

OBAGI SKINTRINSIQ ANTIOXIDANT PROTOCOL 
avobenzone, homosalate, octisalate. octocrylene, and oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-906

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-906-06	1 in 1 BOX; Type 0: Not a Combination Product	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, DROPPER	30 mL
Part 4	1 BOTTLE, PUMP	30 mL
Part 5	1 TUBE	48 g

Part 1 of 5

OBAGI NU-DERM GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) 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) 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 PROFESSIONAL-C SERUM 
face and neck (excluding shaving preparations) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)
INGR	PROPYLENE CARBONATE (UNII: 8D08K3S51E)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER; 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 PROFESSIONAL-C PEPTIDE COMPLEX 
moisturizing lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)
INGR	ALMOND OIL (UNII: 66YXD4DKO9)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	HYDROCHLORIC ACID (UNII: QTT17582CB)
INGR	IMIDUREA (UNII: M629807ATL)
INGR	KINETIN (UNII: P39Y9652YJ)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
INGR	PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
INGR	SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INGR	SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	WATER (UNII: 059QF0KO0R)
INGR	ZEATIN (UNII: 7I6OOJ9GR6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		30 mL 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

PROFESSIONAL-C SUNCARE BROAD SPECTRUM SPF 30  SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Item Code (Source)	NDC: 62032-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.9 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-050-54	1 in 1 CARTON
1		48 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	M020	08/01/2021

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

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
G.S.COSMECEUTICAL USA, INC.		017014734	manufacture(62032-906)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(62032-906)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(62032-906)

Establishment
Name	Address	ID/FEI	Business Operations
TENCO ASSEMBLIES, INC		075535609	pack(62032-906)