Active Ingredient
Zinc Oxide 24.08%
Coppertone Pure And Simple Baby Sunscreen Spf 50 Lotion
FDA Label NDC 66800-2871
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 Pure And Simple Baby Sunscreen Spf 50 (NDC 66800-2871). 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 ingredient, 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 use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash 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
■ shake well before each 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
■ protect this product from excessive heat and direct sun
■ may stain or damage some fabrics or surfaces
Inactive Ingredients
water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl pelargonate, ethylhexyl methoxycrylene, polyester-27, tocopherol, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, 1,2-hexanediol, caprylyl glycol
Questions?
1-866-288-3330
Package Label.Principal Display Panel
Coppertone
Zinc Oxide Sunscreen
Pure&Simple
#1 Pediatrician Recommended Sunscreen Brand
Baby
50
100% Mineral Sun Protection
Hypoallergenic & Tear Free Suitable for Sensitive Skin
Free of Oxybenzone, Octinoxate, PABA, Parabens, Dyes, Fragrance
Water Resistant (80 Minutes)
Broad Spectrum SPF 50
* Please review the disclaimer below.
