Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3%................Sunscreen
Homosalate 10%...............Sunscreen
Octisalate 5%....................Sunscreen
Octocrylene 7%.................Sunscreen
Cover Me Sunscreen
FDA Label NDC 68828-280
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jafra Cosmetics International for the product Cover Me Sunscreen (NDC 68828-280). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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
Otc - Purpose
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
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.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
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.
Dosage & Administration
Directions:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: Ask a doctor
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
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:
Inactive Ingredient
Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia sinensis Leaf Extract, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Maltodextrin, PEG-100 Stearate, PEG-40 Hydrogenated Castor Oil, Phenethyl Alcohol, Phenoxyethanol, Royal Jelly Powder, Royal Jelly, Silica, Styrene/Acrylates Copolymer, Tetrapeptide-45, Trideceth-9, Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Zingiber Officinale (Ginger) Root Extract.
Package Label.Principal Display Panel
Jafra Royal Boost
Cover Me Sunscreen Broad Spectrum SPF 30
Carton (Ucboostcovermespf30jpg)
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