Label: COPPERTONE KIDS ROLL-ON SUNSCREEN SPF 50- zinc oxide 24.08% lotion
- NDC Code(s): 66800-4026-2
- 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 February 6, 2023
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- Drug Facts
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
■ shake well before use
■ apply liberally 15 minutes before sun exposure
■ 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, especially 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
water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl methoxycrylene, polyester-27, sodium sulfate, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, PEG-12 dimethicone crosspolymer, caprylyl glycol, 1,2-hexanediol, blue 1
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INGREDIENTS AND APPEARANCE
COPPERTONE KIDS ROLL-ON SUNSCREEN SPF 50
zinc oxide 24.08% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4026 Route of Administration SUPRACHOROIDAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24.08 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM SULFATE (UNII: 0YPR65R21J) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) BASIC BLUE 1 (UNII: 92N74OA24D) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SODIUM CHLORIDE (UNII: 451W47IQ8X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) POLYESTER-7 (UNII: 0841698D2F) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-4026-2 75 g in 1 CANISTER; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2023 Labeler - Beiersdorf Inc (001177906)
