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
Drug Label Information
Updated November 14, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Use
- Warnings
- DO NOT USE
- WHEN USING
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
-
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
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g 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 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 Drug M020 11/02/2020 Labeler - Beiersdorf Inc (001177906)