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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  • SPL UNCLASSIFIED SECTION

    Obagi ® Professional-C™ Suncare SPF 30

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    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 - 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
  • INGREDIENTS AND APPEARANCE
    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)
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