OBAGI SKINTRINSIQ ANTIOXIDANT PROTOCOL- avobenzone, homosalate, octisalate. octocrylene, and oxybenzone 
Obagi Cosmeceuticals LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Obagi ® Skintrinsiq Brightening Protocol Kit 10%

Obagi ® Professional-C™ Suncare SPF 30

Drug Facts

Active ingredientsPurpose
Avobenzone 3%Sunscreen
Homosalate 8%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 2.79%Sunscreen
Oxybenzone 3%Sunscreen

Uses

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

Other information

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

Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

SKINTRINSIQ™

ANTIOXIDANT 10%
PROTOCOL KIT

INCLUDES:

OBAGI ®

PRINCIPAL DISPLAY PANEL - Kit Carton

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

OBAGI ®
MEDICAL

Professional-C™
SUNCARE

BROAD SPECTRUM
SPF 30

SUNSCREEN

Net wt. 1.7 oz. (48 g)

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
OBAGI SKINTRINSIQ ANTIOXIDANT PROTOCOL 
avobenzone, homosalate, octisalate. octocrylene, and oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-906
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-906-061 in 1 BOX; Type 0: Not a Combination Product08/01/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 60 mL
Part 21 BOTTLE, PLASTIC 59 mL
Part 31 BOTTLE, DROPPER 30 mL
Part 41 BOTTLE, PUMP 30 mL
Part 51 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 AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
INGRBORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGROLEYL LACTATE (UNII: B3AWW0N3GM)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRSAGE (UNII: 065C5D077J)  
INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRWATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/01/2021
Part 2 of 5
OBAGI NU-DERM TONER 
face and neck (excluding shaving preparations) liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRBORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRHAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRPOTASSIUM ALUM (UNII: 1L24V9R23S)  
INGRSAGE (UNII: 065C5D077J)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRWATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/01/2021
Part 3 of 5
OBAGI PROFESSIONAL-C SERUM 
face and neck (excluding shaving preparations) liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
INGRPROPYLENE CARBONATE (UNII: 8D08K3S51E)  
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGRWATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/01/2021
Part 4 of 5
OBAGI PROFESSIONAL-C PEPTIDE COMPLEX 
moisturizing lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)  
INGRALMOND OIL (UNII: 66YXD4DKO9)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRHYDROCHLORIC ACID (UNII: QTT17582CB)  
INGRIMIDUREA (UNII: M629807ATL)  
INGRKINETIN (UNII: P39Y9652YJ)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRORANGE OIL (UNII: AKN3KSD11B)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRPEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPOLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
INGRPPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
INGRSODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRTETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRWATER (UNII: 059QF0KO0R)  
INGRZEATIN (UNII: 7I6OOJ9GR6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/01/2021
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.9 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-050-541 in 1 CARTON
148 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/01/2021
Labeler - Obagi Cosmeceuticals LLC (790553353)
Establishment
NameAddressID/FEIBusiness Operations
G.S.COSMECEUTICAL USA, INC.017014734manufacture(62032-906)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(62032-906)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(62032-906)
Establishment
NameAddressID/FEIBusiness Operations
TENCO ASSEMBLIES, INC075535609pack(62032-906)

Revised: 3/2023
Document Id: f7fcdec6-1f70-ab52-e053-6294a90a6281
Set id: 53023b16-8d64-4dfc-bc75-b4f248425c4d
Version: 2
Effective Time: 20230328
 
Obagi Cosmeceuticals LLC