Label: TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN CONTINUOUS SPF 30- zinc oxide spray
- NDC Code(s): 36800-351-50
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
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 March 17, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- FLAMMABLE:
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
- apply liberally 15 minutes before sun exposure
- hold can 4-6 inches away from body, spray evenly to ensure complete coverage
- do not spray into face. Spray into hand and apply to face.
- use in well ventilated, but not windy areas
- 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 value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wearl long-sleeved shirts, pants, hats, and sunglasses
- Other Information
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Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Bentonite, Glycerin, C30-38 Olefin/Isopropyl Maleate/ MA Copolymer, Aloe Barbadensis Leaf Juice, Olive Oil Polyglyceryl-6 Esters, Sodium Stearoyl Lactylate, Cetearyl Alcohol, Vitis Vinifera (Grape) Seed Oil, Phenethyl Alcohol, Glyceryl Caprylate, Xanthan Gum, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Tocopherol, Cholecalciferol.
- Label
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INGREDIENTS AND APPEARANCE
TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN CONTINUOUS SPF 30
zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-351 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENTONITE (UNII: A3N5ZCN45C) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SUNFLOWER OIL (UNII: 3W1JG795YI) OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CHOLECALCIFEROL (UNII: 1C6V77QF41) CORN OIL (UNII: 8470G57WFM) GRAPE SEED OIL (UNII: 930MLC8XGG) XANTHAN GUM (UNII: TTV12P4NEE) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-351-50 179 g in 1 CAN; Type 0: Not a Combination Product 12/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/17/2020 Labeler - TOPCO ASSOCIATES LLC (006935977)