Label: CVS HEALTH SPF 30 ULTRA SHEER- 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 January 26, 2023

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  • Active ingredients

    Avobenzone 3.0%, Homosalate 8.0%, Octisalate 5.0%, Octocrylene 4.0%

  • 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 aging caused by the sun
  • 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.

    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 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 in this container from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces
  • Inactive ingredients

    water, tridecyl salicylate, silica, dimethicone, potassium cetyl phosphate, beeswax, benzyl alcohol, glyceryl stearate, PEG-100 stearate, cetyl dimethicone, caprylyl methicone, caprylyl glycol, ethyhexylglycerin, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, behenyl alcohol, xanthan gum, ethylhexyl stearate, acrylates/C12-22 alkyl methacrylate copolymer, disodium EDTA, chlorphenesin, fragrance, trideceth-6, propylene glycol

  • Label

    CVS30751A

    CVS62003A

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH SPF 30 ULTRA SHEER 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-029-0989 mL in 1 TUBE; Type 0: Not a Combination Product10/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/31/2018
    Labeler - CVS PHARMACY (062312574)