Active Ingredient
Octyl salicylate 5%
Octocrylene 9%
Avobenzone 3%
Sun-light Sunscreen
FDA Label NDC 83407-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Indeed Laboratories Inc. for the product Sun-light Sunscreen (NDC 83407-001). 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 inner package, package label.principal display panel, active ingredient, purpose, warnings, otc - keep out of reach of children, dosage & administration, indications and usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Warnings
Warnings:
Do not use
- On damaged or broken skin.
When using this product
- Keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if
- Rash occurs.
Keep out of reach of children
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
- Apply generously (and evenly) 15 minutes before sun exposure.
- Children 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.-2p.m.
- wear long sleeve shirts, pants, hats and sunglasses.
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating.
Indications And Usage
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.
Inactive Ingredient
Inactive ingredients
Water, Butyloctyl salicylate, propanediol, butylene glycol, polyglyceryl-6 stearate, polyglyceryl-6 behenate, aloe barbadensis leaf juice, citric acid, potassium sorbate, sodium benzoate, glycerin, potassium cetyl phosphate, ethylhexylmethoxycrylene, Simmondsia chinensis (jojoba) seed oil, phenoxyethanol, tripeptide-1, ethylhexylglycerin, ammonium, acryloyldimethyltaurate/VP copolymer, Pongamia pinnata seed extradct, caramel, sodium hyaluronate, sodium citrate, butylene glycol, dextran.
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