Label: COPPERTONE EVERY TONE SUNSCREEN SPF 50- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion
- NDC Code(s): 66800-1093-7
- 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 4, 2023
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- Drug Facts
- Active ingredients
- 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
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COPPERTONE EVERY TONE SUNSCREEN SPF 50
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-1093 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) DIMETHICONE (UNII: 92RU3N3Y1O) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) ISODODECANE (UNII: A8289P68Y2) TOCOPHEROL (UNII: R0ZB2556P8) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) ALCOHOL (UNII: 3K9958V90M) GLYCERETH-26 (UNII: NNE56F2N14) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) XANTHAN GUM (UNII: TTV12P4NEE) DOCOSANOL (UNII: 9G1OE216XY) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) GLYCERIN (UNII: PDC6A3C0OX) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) Product Characteristics Color white (White to Off-White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-1093-7 207 g in 1 BOTTLE, PLASTIC; 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)
