Label: CVS HEALTH BABY SPF 50 SUN- octinoxate, octisalate, zinc oxide lotion

  • NDC Code(s): 69842-138-11, 69842-138-22
  • Packager: CVS Pharmacy
  • 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 December 21, 2022

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  • Active ingredients

    Octinoxate 7.5%, Octisalate 5.0%, Zinc Oxide 14.5%

  • 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

    • ​​on damaged or broken skin.

  • ​When using this product​

    keep out of eyes. Rinse with water to remove.

  • 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
    • 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

  • Inactive ingredients

    water, propylene glycol, c12-15 alkyl benzoate, neopentyl glycol diheptanoate, cyclopentasiloxane, cetyl PEG/PPG-10/1 dimethicone, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, aloe barbadensis leaf extract, ethylhexyl palmitate, diazolidinyl urea, methylparaben, propylparaben, sodium chloride

  • Other information

    • protect the product in this container from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces

  • Label

    CVS35232EF

    CVS47134A

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH  BABY SPF 50 SUN
    octinoxate, octisalate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-138
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE145 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-138-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/10/2017
    2NDC:69842-138-22177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/09/2016
    Labeler - CVS Pharmacy (062312574)
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