Label: COPPERTONE SPORT MINERAL SUNSCREEN SPF 50- zinc oxide lotion
- NDC Code(s): 66800-0002-5
- Packager: Beiersdorf Inc
- 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 March 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
Directions
- shake well before use
- apply liberally 15 minutes before sun exposure
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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, expecially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats and sunglasses
- children under 6 months: Ask a doctor
- Other Information
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Inactive Ingredients
Inactive ingredients water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PED-PPG-10/1 dimethicone, propylene glycol, cyclopentasilxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl methoxycrylene, polyester-27, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, PEG-12 dimethicone crosspolymer, 1,2-hexanediol, caprylyl glycol
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INGREDIENTS AND APPEARANCE
COPPERTONE SPORT MINERAL SUNSCREEN SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 240.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYESTER-7 (UNII: 0841698D2F) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) WATER (UNII: 059QF0KO0R) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R) DIMETHICONE (UNII: 92RU3N3Y1O) Product Characteristics Color yellow ((Off white to light yellow)) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-0002-5 148 mL in 1 TUBE; Type 0: Not a Combination Product 11/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2020 Labeler - Beiersdorf Inc (001177906)
