Otc - Active Ingredient
Avobenzone 2.70%
Homosalate 7.00%
Octisalate 4.50%
Octocrylene 9.00%
Age20s Uv Defense Hydro Calming Sunscreen Twin Pack Cream
FDA Label NDC 67225-5034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aekyung Industrial Co., Ltd. for the product Age20s Uv Defense Hydro Calming Sunscreen Twin Pack (NDC 67225-5034). 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, indications & usage, 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
Sunscreen
Indications & Usage
■ 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.
Warnings
For external use only
Otc - Do Not Use
■ on damaged skin or broken skin
Otc - When Using
this product ■ keep out of eyes. Rinse with water to remove.
Otc - Stop Use
and ask a doctor if ■ rash occurs.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact poison control center right away.
Inactive Ingredient
Water, Propanediol, Butyloctyl Salicylate, Polyglyceryl-3 Distearate, Silica, Microcrystalline Cellulose, C13-15 Alkane, Panthenol, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Polyglycerin-3, Poly C10-30 Alkyl Acrylate, Dipropylene Glycol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Benzotriazolyl Dodecyl p-Cresol, Hydroxyacetophenone, Sodium Stearoyl Glutamate, Butylene Glycol, Allantoin, Ammonium Polyacryloyldimethyl Taurate, Cetearyl Alcohol, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Glycol, Glycerin, Disodium EDTA, Oleic Acid, Caprylhydroxamic Acid, Ethanol, Cellulose Gum, 1,2-Hexanediol, Oryza Sativa (Rice) Bran Extract, Scutellaria Baicalenesis Root Extract, Tris(Tetramethylhy- droxypiperidinol) Citrate, t-Butyl Alcohol, Ascorbic Acid, Niacinamide, Tocopheryl Acetate, Saccharomyces Cerevisiae Extract, Hyaluronic Acid, Ceramide NP
Other Safety Information
■ Protect the product in the container from excessive heat and avoid storing it under direct sun.
■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Dosage & Administration
Directions
■ Apply liberally 15 minutes before sun exposure.
■ Children under 6 months of age: Ask a doctor.
■ 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. Todecrease 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-sleeved shirts, pants, hats, and sunglasses.
* Please review the disclaimer below.
