Label: POWDER- zinc oxide, titanium dioxide powder
- NDC Code(s): 61354-061-03
- Packager: Oxygen Development
- 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 February 10, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using
- Stop use
- Keep out of the reach of children
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Directions
Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor.
Reapply: immediately after towel drying. At least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun protections 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: lomit time in the sun, especially from 10 a.m-2p.m. wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
- Iniactive ingredient
- Questions or Comments
- Pimary package
- Secondary package
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INGREDIENTS AND APPEARANCE
POWDER
zinc oxide, titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61354-061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 15.09 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17.55 g in 100 g Inactive Ingredients Ingredient Name Strength JOJOBA OIL (UNII: 724GKU717M) MICA (UNII: V8A1AW0880) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61354-061-03 1 in 1 CARTON 02/23/2021 02/10/2023 1 4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/23/2021 Labeler - Oxygen Development (137098492) Establishment Name Address ID/FEI Business Operations Oxygen development 137098492 manufacture(61354-061)