Label: ULTRA VIOLETTE FUTURE SCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion
- NDC Code(s): 84803-103-15, 84803-103-50
- Packager: Grace and Fire USA Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 5, 2024
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- ACTIVE INGREDIENTS
- PURPOSE
- USE
- WARNINGS
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Directions
- apply liberally and evenly 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- 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 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: Ask a doctor
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Inactive Ingredients
Water, Diisopropyl Adipate, Coco-Caprylate/Caprate, Ethylhexyl Methoxycrylene, C12-15 Alkyl Benzoate, Glyceryl Oleate Citrate, Propanediol, Decyl Glucoside, Polyglyceryl-4 Isostearate, Squalane, Aluminum Starch Octenylsuccinate, Saccharide Isomerate, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Magnesium Aluminum Silicate, Citric Acid, Sodium Citrate, Hydroxyacetophenone, Potassium Cetyl Phosphate, Phenoxyethanol, Polyhydroxystearic Acid, Ammonium Polyacryloyldimethyl Taurate, Lactic Acid, Sodium Hydroxide, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499) - Other Information
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INGREDIENTS AND APPEARANCE
ULTRA VIOLETTE FUTURE SCREEN BROAD SPECTRUM SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84803-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) CI 77499 (UNII: XM0M87F357) SODIUM CITRATE (UNII: 1Q73Q2JULR) SQUALANE (UNII: GW89575KF9) CI 77492 (UNII: EX438O2MRT) LACTIC ACID (UNII: 33X04XA5AT) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) SODIUM HYDROXIDE (UNII: 55X04QC32I) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) WATER (UNII: 059QF0KO0R) GLYCERYL OLEATE CITRATE (UNII: NLE5KIG74K) SACCHARIDE ISOMERATE (UNII: W8K377W98I) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PROPANEDIOL (UNII: 5965N8W85T) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) CITRIC ACID (UNII: 2968PHW8QP) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) PHENOXYETHANOL (UNII: HIE492ZZ3T) AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371) CI 77491 (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84803-103-50 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2024 2 NDC:84803-103-15 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/01/2024 Labeler - Grace and Fire USA Inc. (119357605)