Active Ingredient
AVOBENZONE 2.0%
HOMOSALATE 10.0%
OCTISALATE 5.0%
OCTOCRYLENE 5.0%
OXYBENZONE 5.0%
Sun Shield Sunscreen
FDA Label NDC 66391-3001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winning Solutions for the product Sun Shield Sunscreen (NDC 66391-3001). 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 - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, 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
Warnings
For external use only.
Do not use
- on damaged or broken skin.
- keep out of eyes. Rinse with water to remove.
- rash or irritation develops and lasts.
When using this product
Stop use and ask a doctor if
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control center right away.
Directions
- apply generously 15 minutes before sun exposure.
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- under 6 months of age: ask a doctor
- 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. and wear long-sleeved shirts, pants, hats and sunglasses. For use on skin only.
Reapply:
Inactive Ingredients
water, glycerin, stearic acid, cetyl alcohol, aloe barbadensis leaf, c12-15 alkyl benzoate, dea-cetyl phosphate, vp/eicosene copolymer, phenoxyethanol, dimethicone, triethanolamine, carbomer, titanium dioxide, glycereth-2 cocoate, tocopheryl acetate, retinyl palmitate, iodopropynyl butylcarbamate, chamomilla recutitita (matricaria) flower extract
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