Otc - Active Ingredient
Active ingredients
Avobenzone: 3%
Homosalate: 7.3%
Octisalate: 5.0%
Uv Restore Face Serum Sunscreen Spf 50 Lotion
FDA Label NDC 68577-238
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa for the product Uv Restore Face Serum Sunscreen Spf 50 (NDC 68577-238). 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, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Uses
Uses
- help 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
Warnings
For external use only
Otc - Do Not Use
Do not useon damaged or broken skin
Otc - When Using
When using this product, keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor ifrash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions
- 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-sleeve shirts, pants, hats, and sunglasses.
- children under 6 months: Ask doctor
Inactive Ingredient
Inactive ingredients
Water, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Dripropylene Glycol, Ethylhexyl Methoxycrylene, Betaine, Shorea Stenoptera Seed Butter, VP/Hexadecene Copolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Phenoxyethanol, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Butylene Glycol, Bisabolol, Carbomer, Dipotassium Glycyrrhizate, Panthenol, Oryza Sativa (Rice) Bran Extract, Sodium PCA, Sodium Lactate, Tromethamine, Arginine, Aspartic Acid, PCA, Propanediol, Ceramide NP, Glycine, Alanine, 1,2-Hexanediol, Sodium Hyaluronate, Glycolipids, Serine, Valine, Centella Asiatica Extract, Isoleucine, Proline, Threonine, Histidine, Phenylalanine, Caprylyl Glycol, Sodium Benzoate, Acetyl Hexapeptide-8.
Other Information
Other information
- protect the product in this container from excessive heat and direct sun
Questions Or Comments
Questions or comments?
Package Label.Principal Display Panel
Tube (Faceserumspf50 Pp)
Carton (Faceserumspf50 Sp)
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