Label: ANTIOXIDANT SUNSCREEN SPF 40- octinoxate and zinc oxide lotion
- NDC Code(s): 51326-829-03
- Packager: Topiderm, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 13, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure
- Re-apply after 80 minutes of swimming or sweating, anytime after towel drying, or at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Use on children under 6 months of age: consult a doctor.
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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 sunscreen measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
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Inactive ingredients
Ascorbic Acid, Ascorbyl Palmitate, Butylene Glycol, Camellia Sinensis (Green Tea) Leaf Extract, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Ceresin, Chitosan, Cyclomethicone, Diazolidinyl Urea, Disodium EDTA, Laureth-7, Lauryl PEG/PPG-18/18 Methicone, Methylparaben, Phospholipids, Polyacrylamide, Propyl Gallate, Propylene Glycol, Propylparaben, Purified Water, Retinyl Palmitate, Sodium Chloride, Superdioxide Dismutase, Tocopheryl Acetate, Ubiquinone (Co Q-10).
- PRINCIPAL DISPLAY PANEL - 105 ml Bottle Label
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INGREDIENTS AND APPEARANCE
ANTIOXIDANT SUNSCREEN SPF 40
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51326-829 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CERESIN (UNII: Q1LS2UJO3A) CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (UNII: SBD1A2I75N) CYCLOMETHICONE (UNII: NMQ347994Z) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) LAURETH-7 (UNII: Z95S6G8201) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) METHYLPARABEN (UNII: A2I8C7HI9T) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM CHLORIDE (UNII: 451W47IQ8X) SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) UBIDECARENONE (UNII: EJ27X76M46) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51326-829-03 105 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/28/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 07/28/2000 Labeler - Topiderm, Inc. (049121643) Registrant - Topiderm, Inc. (049121643) Establishment Name Address ID/FEI Business Operations Topiderm, Inc. 049121643 MANUFACTURE(51326-829) Establishment Name Address ID/FEI Business Operations Topix Pharmaceuticals, Inc. 117745066 PACK(51326-829)
