Label: HYDRATING PROTECTION SUNSCREEN CVS- avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% oxybenzone 6.0% lotion

  • 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 December 12, 2017

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  • ACTIVE INGREDIENT

    Active ingredients                                                               Purpose
    Avobenzone 3%...................................................................Sunscreen
    Homosalate 15%..................................................................Sunscreen
    Octisalate 5%.......................................................................Sunscreen
    Octocrylene 10%..................................................................Sunscreen
    Oxybenzone 6%..................................................... .............Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn

  • WARNINGS

    Warnings
    For external use only
    Do not use on damaged or broken skin
    When using this product keep out of eyes. Rinse with water to remove.
    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    • apply liberally 15 minutes before sun exposure
    • reapply: • after 80 minutes of swimming or sweating
    • immediately after towel drying • 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 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate
    Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer,
    Acrylates/Dimethicone Copolymer, Adipic Acid/Diglycol Crosspolymer, Avena
    Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel
    Flour, Beeswax, BHT, Bisabolol, Cyclopentasiloxane,
    Dipotassium Glycyrrhizate, Disodium EDTA,
    Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl
    Stearate, Hydrated Silica, Hydrolyzed Oat Protein,
    PEG-100 Stearate, Phenoxyethanol, Polyester-8,
    Potassium Palmitoyl Hydrolyzed Oat Protein,
    Styrene/Acrylates Copolymer,Triethanolamine, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDRATING PROTECTION SUNSCREEN  CVS
    avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% oxybenzone 6.0% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    OAT (UNII: Z6J799EAJK)  
    OATMEAL (UNII: 8PI54V663Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-054-0388 mL in 1 PACKAGE; Type 0: Not a Combination Product02/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/16/2017
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(69842-054)