Active Ingredient
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 10%
Sunscreen
FDA Label NDC 61354-047
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development, Llc for the product Sunscreen (NDC 61354-047). 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, uses, warnings, directions, inactive ingredients, package, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Helps prevent sunburn. If used as directed with another sun protection measures (see Directions), decreasses the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only. Do not use on damage 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 rigth away
Directions
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Reapply at least every 2 hours.
Sun protection meassures: Spending time in the sun increasses 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, specially from 10 am - 2 pm, wear long-sleeved shirts, pants, hats and sunglasses.
Inactive Ingredients
Isododecane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica, VP/Eicosene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate
Package
61354-047-01_aw (Art 050 Tub 587)
61354-047-02_aw (Art 050 Uni 1347)
61354-047-03_aw (Art 100108)
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