Label: SPF 30 SUNSCREEN- zinc oxide, titanium dioxide lotion
- NDC Code(s): 83294-101-18
- Packager: CLEURE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 27, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
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 • Children under 6 months of age: ask a doctor • 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 of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2pm • wear long-sleeved shirts, pants, hats and sunglasses. - INACTIVE INGREDIENTS
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPF 30 SUNSCREEN
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83294-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.51 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE 350 (UNII: 2Y53S6ATLU) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) STEARETH-21 (UNII: 53J3F32P58) ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) STEARETH-2 (UNII: V56DFE46J5) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83294-101-18 118 mL in 1 TUBE; Type 0: Not a Combination Product 08/22/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/22/2022 Labeler - CLEURE (116355659)