Label: BRUSH ON BLOCK MINERAL POWDER SUNSCREEN TRANSLUCENT- titanium dioxide, zinc oxide powder
- NDC Code(s): 58274-011-01
- Packager: SPF Ventures, LLC
- 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 January 20, 2023
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- Active Ingredients
- Purpose
- Uses
- Warnings
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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 10am - 2pm • Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor
- Inactive Ingredients
- Other Information
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BRUSH ON BLOCK MINERAL POWDER SUNSCREEN TRANSLUCENT
titanium dioxide, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58274-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.21 g in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.06 g in 1 g Inactive Ingredients Ingredient Name Strength LAUROYL LYSINE (UNII: 113171Q70B) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LEVOMENOL (UNII: 24WE03BX2T) ETHYL FERULATE (UNII: 5B8915UELW) MICA (UNII: V8A1AW0880) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) FERRIC OXIDE RED (UNII: 1K09F3G675) RICE BRAN OIL (UNII: LZO6K1506A) BORON NITRIDE (UNII: 2U4T60A6YD) SAFFLOWER OIL (UNII: 65UEH262IS) CHAMOMILE (UNII: FGL3685T2X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58274-011-01 3.4 g in 1 TUBE; Type 0: Not a Combination Product 01/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/20/2023 Labeler - SPF Ventures, LLC (055483891)