Label: COVER ME SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene 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 June 11, 2020

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Avobenzone 3%................Sunscreen
    Homosalate 10%...............Sunscreen
    Octisalate 5%....................Sunscreen
    Octocrylene 7%.................Sunscreen

  • PURPOSE

    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
  • 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.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor

    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-sleeve shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Inactive ingredients
    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia sinensis Leaf Extract, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Maltodextrin, PEG-100 Stearate, PEG-40 Hydrogenated Castor Oil, Phenethyl Alcohol, Phenoxyethanol, Royal Jelly Powder, Royal Jelly, Silica, Styrene/Acrylates Copolymer, Tetrapeptide-45, Trideceth-9, Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Zingiber Officinale (Ginger) Root Extract.

  • PRINCIPAL DISPLAY PANEL

    Jafra Royal Boost

    Cover Me Sunscreen Broad Spectrum SPF 30

    Carton

  • INGREDIENTS AND APPEARANCE
    COVER ME SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-280
    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) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ARGININE (UNII: 94ZLA3W45F)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ROYAL JELLY (UNII: L497I37F0C)  
    TRIDECETH-9 (UNII: X9HD79I514)  
    COCOA (UNII: D9108TZ9KG)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GINGER (UNII: C5529G5JPQ)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-280-0150 mL in 1 TUBE; Type 0: Not a Combination Product06/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/12/2018
    Labeler - Jafra Cosmetics International (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-280)
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