Otc - Active Ingredient
Active ingredientsPurpose
Octocrylene 8%sunscreen
Zinc Oxide 8%sunscreen
Homosalate 7%sunscreen
Ethylhexyl Salicylate 5%sunscreen
Avobenzone 3%sunscreen
Orlaskin Spf50 Antioxidant Soothingcomplex Sunscreen Cream
FDA Label NDC 87582-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yapheon Health Industry Co., Ltd. for the product Orlaskin Spf50 Antioxidant Soothingcomplex Sunscreen (NDC 87582-003). 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, warnings, dosage & administration, indications & usage, 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,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
Warnings
Warnings
For external use only
Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with
watertoremove
· Stop use and ask a doctor if rash occurs
Dosage & Administration
apply at least every 2 hours
· Apply generously and evenly 15 minutes before sun
Use a water resistant sunscreen if swimming or sweating
Indications & Usage
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. to 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor.
Inactive Ingredient
Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate,Glycerin, Isoamyl Laurate, Propanediol, Dimethicone,Polyglyceryl-6 Stearate, Acrylates/OctylacrylamideCopolymer, Trimethylsiloxysilicate, Cetearyl Alcohol,Polyhydroxystearic Acid, Phenoxyethanol, Stearic Acid,Panthenol, Tocopherol, Ethylhexylglycerin, HydrogenDimethicone, Bisabolol, Allantoin,Arginine, AscorbylTetraisopalmitate, Centella Asiatica Extract, HydrolyzedHyaluronic Acid, Butylated Hydroxytoluene
Package Label.Principal Display Panel
Labeling (87582 003 01)
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