Active Ingredients
Octisalate 3.2%
Octocrylene 6%
Leg And Body Makeup Broad Spectrum Spf 25 Liquid
FDA Label NDC 84203-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Baxter Of California, Llc for the product Leg And Body Makeup Broad Spectrum Spf 25 (NDC 84203-002). 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, do not use, when using this product, keep out of reach of children., stop use and ask a doctor if, 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
Do Not Use
on damaged or broken skin
When Using This Product
keep out of eyes. Rinse with water to remove.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Stop Use And Ask A Doctor If
rash occurs
Directions
For sunscreen use: ● apply liberally 15 minutes before sun exposure ● reapply at least every 2 hours ● use a water resistant sunscreen if swimming or sweating ● 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-sleeved shirts, pants, hats, and sunglasses ● children under 6 months of age: Ask a doctor
Other Information
protect the product in this container from excessive heat and direct sun
Inactive Ingredients
water, cyclopentasiloxane, isododecane, isononyl isononanoate, glycerin, cetyl PEG/PPG 10/1 dimethicone, dimethicone, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, disteardimonium hectorite, phenoxyethanol, polybutene, methylparaben, alcohol denat., chlorphenesin, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, butylparaben, aluminum hydroxide, sodium hydroxide, isobutane, dipropylene glycol, sodium citrate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides
Otc - Questions
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