Active Ingredient
Zinc Oxide 24.08%
Coppertone Waterbabies Pure And Simple Sunscreen Spf 50 Spray
FDA Label NDC 66800-2880
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 66800-2880). 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 - when using, otc - stop use, otc - keep out of reach of children, directions, 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
Flammable: Do not use near heat, flame, or while smoking
Otc - When Using
When using this product
■ keep away from face to avoid breathing it
■ keep out of eyes. Rinse with water to remove.
■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.
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
■ 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
■ protect this product from excessive heat and direct sun
■ store between 20˚ to 25˚C (68˚ to 77˚F)
■ may stain or damage some fabrics or surfaces
Inactive Ingredients
isobutane, 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, cetyl dimethicone, triethoxycaprylylsilane, beeswax, tocopherol (vitamin E), hydroxyacetophenone, sodium chloride, PEG-12 dimethicone crosspolymer, 1,2-hexanediol, caprylyl glycol, caprylyl methicone
Questions?
1-866-288-3330
Package Label.Principal Display Panel
Coppertone
Zinc Oxide Snscreen Spray
Pure&Simple
50
100% Mineral Sun Protection
Hypoallergenic
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.
