Label: COPPERTONE DEFEND AND CLEAR- octinoxate, octisalate, zinc oxide lotion
- NDC Code(s): 66800-3641-3, 66800-3641-6
- 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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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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INGREDIENTS AND APPEARANCE
COPPERTONE DEFEND AND CLEAR
octinoxate, octisalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-3641 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9.7 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) BENZYL ALCOHOL (UNII: LKG8494WBH) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORPHENESIN (UNII: I670DAL4SZ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) GLYCERIN (UNII: PDC6A3C0OX) DICAPRYLYL ETHER (UNII: 77JZM5516Z) POLYESTER-7 (UNII: 0841698D2F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-3641-3 88 g in 1 TUBE; Type 0: Not a Combination Product 11/02/2020 2 NDC:66800-3641-6 177 g 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)