Label: SHEER SUNSCREEN SPF 30 CVS HEALTH- avobenzone 2% homosalate 5.5% octisalate 4.5% octocrylene 4% lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 11, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                           Purpose
    Avobenzone 2.00%..........................Sunscreen
    Homosalate 5.50%...........................Sunscreen
    Octisalate 4.50%..............................Sunscreen
    Octocrylene 4.00%...........................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Use • 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
    • 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
    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 ingredients

    Water
    Ethylhexyl Benzoate
    Cetearyl Alcohol
    Diisopropyl Adipate
    VP/Eicosene Copolymer
    Glycerin
    Dimethicone
    Neopentyl Glycol Diheptanoate

    Jojoba Alcohol
    Butyrospermum Parkii (Shea) Butter
    Mangifera Indica (Mango) Fruit Extract
    Passiflora Incarnata Fruit Extract
    Psidium Guajava Fruit Extract
    Aloe Barbadensis Leaf Extract
    Tocopheryl Acetate
    Potassium Jojobate
    Simmondsia Chinensis (Jojoba) Butter
    Mangifera Indica (Mango) Seed Butter
    Polymethylsilsesquioxane
    Mica
    Titanium Dioxide
    Propylene Glycol Dibenzoate
    Acrylates/C10-30 Alkyl Acrylate Crosspolymer
    Xanthan Gum
    Paraffin
    Coco-Glucoside
    Colocasia Antiquorum Root Extract
    Carica Papaya (Papaya) Fruit Extract
    Plumeria Acutifolia Flower Extract

    Sodium Ascorbyl Phosphate
    Panthenol
    Dicetyl Phosphate
    Ceteth-10 Phosphate
    Disodium EDTA
    Propanediol
    Sodium Hydroxide
    Phenoxyethanol
    Methylparaben
    Propylparaben
    Fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SHEER SUNSCREEN SPF 30  CVS HEALTH
    avobenzone 2% homosalate 5.5% octisalate 4.5% octocrylene 4% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-841
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone2 g  in 100 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate5.5 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate4.5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Diisopropyl Adipate (UNII: P7E6YFV72X)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MANGO JUICE (UNII: IU6I1JNV24)  
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    GUAVA (UNII: 74O70D6VG0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    JOJOBA BUTTER (UNII: XIA46H803R)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    Mica (UNII: V8A1AW0880)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Propylene Glycol Dibenzoate (UNII: EQY32Z1AN4)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Coco Glucoside (UNII: ICS790225B)  
    COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)  
    PAPAYA (UNII: KU94FIY6JB)  
    PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
    Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)  
    Panthenol (UNII: WV9CM0O67Z)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    Ceteth-10 Phosphate (UNII: 4E05O5N49G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Propanediol (UNII: 5965N8W85T)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-841-06236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/15/2017
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-841) , label(69842-841)