Label: COPPERTONE LIMITED EDITION SUNSCREEN SPF 30- avobenzone 2%, homosalate 8%, octisalate 4.5%, octocrylene 7% aerosol, spray
- NDC Code(s): 66800-3026-5
- 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 7, 2023
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- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
■ shake well before each use
■ spray liberally and spread evenly by hand 15 minutes before sun exposure
■ hold container 4 to 6 inches from the skin to apply
■ do not spray directly into face. Spray on hands then apply to face.
■ do not apply in windy conditions
■ use in a well-ventilated area
■ 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
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COPPERTONE LIMITED EDITION SUNSCREEN SPF 30
avobenzone 2%, homosalate 8%, octisalate 4.5%, octocrylene 7% aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-3026 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g Inactive Ingredients Ingredient Name Strength POLYESTER-7 (UNII: 0841698D2F) FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0) ALCOHOL (UNII: 3K9958V90M) ISOBUTANE (UNII: BXR49TP611) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) ASCORBYL PALMITATE (UNII: QN83US2B0N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-3026-5 156 g in 1 CAN; Type 0: Not a Combination Product 11/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2022 Labeler - Beiersdorf Inc (001177906)
