Label: CVS HEALTH SPF 45 SHEER MIST- avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

  • 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 November 1, 2022

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

  • Active ingredients

    Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 2.35%, Oxybenzone 6.0%

  • 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

  • FLAMMABLE:

    • do not use near heat, flame or while smoking
    • avoid long term storage above 104°F (40°C)

  • ​Do not use

    • ​​on damaged or broken skin

  • When using this product

    • keep out of eyes. Rinse with water to remove. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120° F.

  • ​Stop use and ask doctor if

    • rash occurs.
  • ​Keep out of reach of children.

    ​If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • hold can 4-6 inches away from body, spray evenly to ensure complete coverage
    • do not spray into face. Spray into hand and apply to face.
    • use in well ventilated, but not windy areas
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • 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-sleeved shirts, pants, hats, and sunglasses

  • Other Information

    • protect the product of this container from excessive heat and direct sun

    • may stain or damage some fabrics, materials or surfaces

  • Inactive ingredients

    alcohol denat., acrylates/octylacrylamide copolymer, cyclopentasiloxane, dimethicone, trisiloxane, polysilicone-15, acrylates/dimethicone copolymer, PPG-5-ceteth-20, tocopherol, ascorbyl palmitate, retinyl palmitate, phospholipids, water, beta-carotene, fragrance

  • Label

    CVS58536A

    CVS34627A

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH  SPF 45 SHEER MIST
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE300 mg  in 10 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1500 mg  in 10 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE500 mg  in 10 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE235 mg  in 10 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE600 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    WATER (UNII: 059QF0KO0R)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    ALCOHOL (UNII: 3K9958V90M)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-120-24142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/19/2016
    Labeler - CVS Pharmacy (062312574)