Otc - Active Ingredient
Active ingredientsPurpose
Octocrylene 10%sunscreen
Ethylhexyl Methoxycinnamate 7%sunscreen
Ethylhexyl Salicylate 5%.sunscreen
Avobenzone 3%.sunscreen
Orlaskin Hydrating Sunscreen Spf 50 Spray
FDA Label NDC 87582-004
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 Hydrating Sunscreen Spf 50 (NDC 87582-004). 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, dosage & administration, warnings, inactive ingredient, indications & usage, 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 sunprotection measures, decreases the risk ofskin 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
Dosage & Administration
Directions
·Apply generously and evenly 15 minutes
before sun exposure
· Reapply at least every 2 hours
Use a water resistant sunscreen if
swimming or sweating
Warnings
Warnings
· For external use only Do not use on damaged or broken skinRinse with water to remove
· When using this product keep out of eyes.
Stop use and ask a doctor if rash occurs
Inactive Ingredient
Inactive Ingredients
Cyclopentasiloxane, Isododecane, Ethanol,C12-15 Alkyl Benzoate,Acrylates/Octylacrylamide Copolymer,VP/Eicosene Copolymer, Caprylic/CapricTriglyceride, Panthenol, Tocopherol,Bisabolol, Ascorbyl Tetraisopalmitate,Butylated Hydroxytoluene
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.
Package Label.Principal Display Panel
Labeling (87582 004 01)
Labeling (87582 004 01 2)
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