Label: CVS HEALTH SPF 55 CLEAR FACE- avobenzone, homosalate, octisalate, octocrylene, oxybenzone 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 March 10, 2018

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

  • Active ingredients

    Avobenzone 2.7%, Homosalate 4.0%, Octisalate 4.5%, Octocrylene 6.0%, Oxybenzone 4.5%

  • Purpose

    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

    ​Do not use on damaged or broken skin

  • WHEN USING

    ​When using this product​ keep out of eyes. Rinse with water to remove.

  • STOP USE

    ​Stop use and ask doctor if​ rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    ​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
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months of age: 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

  • Other information

    • protect this product from excessive heat and direct sun

    • may stain or damage some fabrics, materials or surfaces

  • Inactive ingredients

    acrylates/dimethicone copolymer, BHT, bisabolol, butylene glycol, C12-15 alkyl
    benzoate, capryloyl glycine, caprylyl glycol, cedrus atlantica bark extract, cetyl
    dimethicone, chlorphenesin, cinnamomum zeylanicum bark extract, dimethicone,
    disodium EDTA, ethylhexyl stearate, ethylhexylglycerin, glycerin, mannan,
    neopentyl glycol diheptanoate, phenoxyethanol, polyester-7, portulaca oleracea
    extract, propylene glycol, sarcosine, silica, sodium polyacrylate, steareth-100,
    steareth-2, styrene/acrylates copolymer, trideceth-6, water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    CVS Health SPF 55

    Clear Face Lotion

    3.0 FL OZ (88 mL) Label

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH  SPF 55 CLEAR FACE
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-176
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE40 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARETH-2 (UNII: V56DFE46J5)  
    WATER (UNII: 059QF0KO0R)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYESTER-7 (UNII: 0841698D2F)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)  
    SARCOSINE (UNII: Z711V88R5F)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-176-0988 mL in 1 TUBE; Type 0: Not a Combination Product03/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/10/2018
    Labeler - CVS Pharmacy (062312574)
    Registrant - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(69842-176)