Label: OBAGI SKINTRINSIQ ANTIOXIDANT PROTOCOL- avobenzone, homosalate, octisalate. octocrylene, and oxybenzone kit
- NDC Code(s): 62032-050-54, 62032-906-06
- Packager: Obagi Cosmeceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 28, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
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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
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
- PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
-
INGREDIENTS AND APPEARANCE
OBAGI SKINTRINSIQ ANTIOXIDANT PROTOCOL
avobenzone, homosalate, octisalate. octocrylene, and oxybenzone kitProduct 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) gelProduct 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) liquidProduct 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) liquidProduct 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 lotionProduct 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 creamProduct 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)