Active Ingredients
Avobenzone 2.80%
Homosalate 6.50%
Octisalate 4.50%
Octocrylene 9.00%
Rejuran Skin Barrier Sunscreen Cream
FDA Label NDC 88050-001
12 label sections · Submitted to the FDA by Pharmaresearch Usa, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmaresearch Usa, Inc. for the product Rejuran Skin Barrier Sunscreen (NDC 88050-001). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, 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
Purpose
Sunscreen
Uses
• 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.
Do Not Use
Do not use on damaged or broken skin.
When Using This Product
When using this product keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor
Stop use and ask a doctor if rash occurs.
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
• 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. 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 10a.m.- 2p.m.
• wear long-sleeved shirts, pants, hats, and sun glasses
Other Information
• protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Water, Dipropylene Glycol, Ethylhexyl Methoxycrylene, Propanediol, Benzotriazolyl Dodecyl p-Cresol, Butyloctyl Salicylate, Cetearyl Olivate, 1,2-Hexanediol, Methyl Methacrylate Crosspolymer, Panthenol, Phenyl Trimethicone, Sorbitan Olivate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Vinyl Dimethicone, C15-19 Alkane, Cetearyl Alcohol, Hydroxyacetophenone, Glyceryl Stearate, Hydrolyzed DNA, Polyacrylate Crosspolymer-6, Sodium Stearoyl Glutamate, Carbomer, Tromethamine, Sodium Hyaluronate, Lauryl Glucoside, Disodium EDTA, Ectoin, Glycerin, Sparassis Crispa Extract, Pinus Pinaster Bark Extract
Package Label
Sunscreen_unitbox (Sunscreen Unitbox)
Sunscreen_label_container (Sunscreen Label Container)
Sunscreen_container (Sunscreen Container)
* Please review the disclaimer below.
