Label: COPPERTONE KIDS TEAR FREE MINERAL SUNSCREEN SPF 50- octinoxate 7.5%, octisalate 5%, zinc oxide 14.5% lotion
- NDC Code(s): 66800-2450-8
- 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 16, 2023
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- Drug Facts
- Active ingredients
- Purpose
- Uses
- 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, propylene glycol, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, cyclopentasiloxane, cetyl PEG/PPG-10/1 dimethicone, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, aloe barbadensis leaf extract, ethylhexyl palmitate, diazolidinyl urea, methylparaben, propylparaben, sodium chloride
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INGREDIENTS AND APPEARANCE
COPPERTONE KIDS TEAR FREE MINERAL SUNSCREEN SPF 50
octinoxate 7.5%, octisalate 5%, zinc oxide 14.5% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-2450 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.5 g in 100 g Inactive Ingredients Ingredient Name Strength PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO) ALOE VERA LEAF (UNII: ZY81Z83H0X) ETHYLHEXYL PALMITATE (UNII: 2865993309) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CHLORIDE (UNII: 451W47IQ8X) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) Product Characteristics Color white ((Off white to pale yellow)) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-2450-8 237 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/04/2021 Labeler - Beiersdorf Inc (001177906)
