Label: CHEM FREE SPF 30- zinc oxide cream

  • NDC Code(s): 59958-404-01
  • Packager: Owen Biosciences, Inc.
  • 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 16, 2023

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  • Active Ingredients Purpose

    Zinc Oxide 21.50%...... Sunscreen   

  • Uses

    • Helps protect against sunburn
    • Higher SPF gives more sunburn protection
    • provides moderate protection against sunburn
  • Warnings

    For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash and irritation develops and lasts. Avoid contact with eyese. If product gets into eyes, rinse thoroughly with water.  Keep out of reach of children. If swallowed, get medicl help or contact poison control center right away.

  • Directions

    • Apply evenly to skin before exposure to sun and as needed
    • Reapply as needed or after towel drying or swimming
    • Children under 6 months, ask doctor.
  • Inactive Ingredients

  • ES SPF 30.jpg

    ES SPF 30.jpg

  • INGREDIENTS AND APPEARANCE
    CHEM FREE SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-404
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION21 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 35 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) 12 g  in 100 g
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 8 g  in 100 g
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) 2.8 g  in 100 g
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) 1.9 g  in 100 g
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 1.8 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59958-404-0150 g in 1 TUBE; Type 0: Not a Combination Product07/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/19/2017
    Labeler - Owen Biosciences, Inc. (790003045)
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