Active Ingredients
Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%
Coppertone Complete Sunscreen Spf 45 Lotion
FDA Label NDC 66800-8159
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beierdorf Inc for the product Coppertone Complete Sunscreen Spf 45 (NDC 66800-8159). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, directions, other information, questions?, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Use
■ helps prevent sunburn
Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ apply liberally 15 minutes before sun exposure
■ reapply:
■ after 40 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
■ protect this product from excessive heat and direct sun
■ may stain or damage some fabrics or surfaces
Questions?
1-866-288-3330
Inactive Ingredients
water, alcohol denat., butyloctyl salicylate, silica, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, glyceryl stearate, tapioca starch, behenyl alcohol, butylene glycol dicaprylate/dicaprate, C12-15 alkyl benzoate, cetearyl alcohol, copernicia cerifera (carnauba) wax, dibutyl adipate, tocopherol (Vitamin E), sodium ascorbyl phosphate, silica dimethyl silylate, sodium stearoyl glutamate, glyceryl behenate, polyglyceryl-6 octastearate, diethylhexyl syringylidenemalonate, phenoxyethanol, xanthan gum, ethylhexylglycerin, hydroxyacetophenone, disodium EDTA, glycerin, sodium hyaluronate, cetyl alcohol
Package Label.Principal Display Panel
Coppertone® Sunscreen Lotion
Complete Face 45
Proven UVA/UVB Protection
+Hydrates
+Weightless & Oil Free
Free of Oxybenzone, Octinoxate, Dyes & PABA
Water Resistant (40 Minutes)
Broad Spectrum SPF 45
* Please review the disclaimer below.
