Active Ingredients
Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%
Coppertone Waterbabies Pure And Simple Sunscreen Spf 50 Lotion
FDA Label NDC 66800-4839
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beiersdorf Inc for the product Coppertone Waterbabies Pure And Simple Sunscreen Spf 50 (NDC 66800-4839). 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, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
■ helps prevent sunburn
■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
For external use only
Otc - Do Not Use
Do not useon damaged or broken skin
Otc - When Using
When using this productkeep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor ifrash occurs
Otc - Keep Out Of Reach Of Children
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 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
■ protect this product from excessive heat and direct sun
■ may stain or damage some fabrics or surfaces
Inactive Ingredients
water, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol, VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, aloe barbadensis leaf juice,
tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide,
disodium EDTA, sodium ascorbyl phosphate
Questions?
1-866-288-3330
Package Label.Principal Display Panel
Coppertone ®Sunscreen Lotion
Waterbabies Light Lotion
SPF50
Formulated with Vitamin E
Water Resistant (80 Minutes)
Broad Spectrum SPF 50
6 FL OZ (177 mL)
* Please review the disclaimer below.
