Otc - Active Ingredient
Allantoin 0.5%
Avobenzone 2.7%
Homosalate 13.5%
Octisalate 4.5%
Vitaran Rejuvena Suncare Cream
FDA Label NDC 87435-1000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Br Pharm Co. , Ltd. for the product Vitaran Rejuvena Suncare (NDC 87435-1000). 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
Skin Protectant
Sunscreen
Indications & Usage
■ Helps prevent sunburn.
■ If used as directed with other sun protection measures (see Driections), decreases the risk of skin cancer and early skin aging caused by the sun
■ temporarily protects and helps relieve chapped or cracked skin
Warnings
For external use only
Otc - Do Not Use
■ on damaged or broken skin.
Otc - When Using
■ keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if ■ rash occurs.
■ condition worsens ■ symptoms last more than 7 days
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact poison control center right away
Dosage & Administration
■ apply liberally 15 minutes before sun exposure.
■ children under 6 months of age: Ask a doctor.
■
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-sleeved shirts, pants, hats, and sunglasses
■ reapply at least every 2 hours.
■ use a water-resistant sunscreen if swimming or sweating
Other Safety Information
■ Protect the product in the container from excessive heat and avoid storing it under direct sun.
Inactive Ingredient
Water
Betaine
Butylene Glycol
Cyclohexasiloxane
1,2-Hexanediol
Niacinamide
Polymethylsilsesquioxane
Glyceryl Stearate
PEG-100 Stearate
Cetearyl Alcohol
Palmitic Acid
Stearic Acid
Ammonium Acryloyldimethyltaurate/VP Copolymer
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Tromethamine
Ethylhexylglycerin
Sodium DNA
Adenosine
Disodium EDTA
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