Label: CVS HEALTH BABY SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

  • Category: HUMAN OTC DRUG LABEL

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 9, 2022

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  • Active ingredients

    Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 2.0%, Oxybenzone 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 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 a 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
    • 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
    • children under 6 months: Ask a doctor
  • 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, sorbitol, VP/eicosene copolymer, stearic acid, styrene/acrylates copolymer, aloe barbadensis leaf juice, triethanolamine, sorbitan isostearate, chamomilla recutita (matricaria) flower extract, propylene glycol, benzyl alcohol, dimethicone, tocopherol (vitamin E), polyglyceryl-3 distearate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, phenoxyethanol, capryloyl glycine, undecylenoyl glycine

  • Label

    CVS38506A

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH  BABY SPF 50
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE130 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHAMOMILE (UNII: FGL3685T2X)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-109-25170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/23/2015
    Labeler - CVS Pharmacy (062312574)