CVS HEALTH SPF 55 CLEAR FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [CVS PHARMACY]

CVS HEALTH SPF 55 CLEAR FACE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [CVS PHARMACY]
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NDC 69842-176-09
Set ID 66fc557c-da5c-51eb-e053-2991aa0a90cd
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART352
  • 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)

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