Label: CREAM OIL SUNSCREEN- zinc oxide, titanium dioxide sunscreen cream
- NDC Code(s): 59958-408-01, 59958-408-02
- 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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- Official Label (Printer Friendly)
- Active Ingredients Purpose
- Uses
- Warnings
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Directions
Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: ask doctor.
Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10a.m. - 2p.m.
wear long sleeve shirts, pants, hats and sunglasses.
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating - Other Information
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CREAM OIL SUNSCREEN
zinc oxide, titanium dioxide sunscreen creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59958-408 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 21 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.25 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 32.6 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59958-408-02 1 in 1 CARTON 04/04/2020 1 NDC:59958-408-01 50 g in 1 TUBE; 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 04/04/2020 Labeler - Owen Biosciences, Inc. (790003045) Establishment Name Address ID/FEI Business Operations Owen Biosciences, Inc. 790003045 manufacture(59958-408)