Otc - Active Ingredient
Zinc Oxide 17.8%
The following Structured Product Label (SPL) was submitted to the FDA by Cj Olive Young Corporation for the product Bring Green Tea Tree Cica Suncream (NDC 81540-102). 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.
Zinc Oxide 17.8%
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 ■ on damaged or broken skin
When using this product ■ keep out of eyes. Rinse with water to remove
Stop use and ask a doctor if ■ rash occurs
■ keep out of reach of children
■ 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
■ protect the product in this container from excessive heat and direct sun
Water, Butyloctyl Salicylate, Caprylic/ Capric Triglyceride, Isododecane, Propanediol, Propylheptyl Caprylate, Polyglyceryl-6 Polyricinoleate, Cetyl Ethylhexanoate, Diphenylsiloxy Phenyl Trimethicone, Niacinamide, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Sodium Chloride, Lauryl Polyglyceryl- 3 Polydimethylsiloxyethyl Dimethicon e, Polyglyceryl-4 Diisostearate/Polyhy- droxystearate/Sebacate, Disteardimonium Hectorite, 1,2-Hexanediol, Triethoxycaprylylsilane, Panthenol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Glyceryl Caprylate, Citrus Aurantium Bergamia (Bergam ot) Fruit Oil, Limonene, Linalool, Tocopherol, Centella Asiatica Extract, Melaleuca Alternifolia (Tea Tree) Extract, Mel aleuca Alternifolia (Tea Tree) Leaf Water, Melaleuca Alternifolia (Tea Tree) Le af Extract, Melaleuca Alternifolia (Tea Tree) Flower/Leaf/Stem Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Chromium Oxide Greens (CI 77288)
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