The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Tata Biotechnology Co., Ltd. for the product Medultima Adventure Sunscreen (NDC 84066-109). 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.
Homosalate 9% ………………………… Sunscreen
Octocrylene 7% …………………………… Sunscreen
Phenylbenzimidazole Sulfonic Acid 4% …… Sunscreen
Ethylhexyl Salicylate 4% ………………………… Sunscreen
Butyl Methoxydibenzoylmethane 3% ………… Sunscreen
Sunscreen
helps prevent sunburn
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. If product is swallowed, get medical help or contact a Poison Control Center immediately.
Directions
• Apply liberally to face and neck 15 minutes before sun exposure
• Use a water-resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• 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 of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from10 a.m.-2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months: Ask a physician
Inactive ingredients Water, Butylene Glycol, Titanium Dioxide, Isononyl Isononanoate, Cetearyl Alcohol, Dimethicone, Glyceryl Stearate, Niacinamide, PEG-100 Stearate, Sodium Hydroxide, Potassium Cetyl Phosphate, Silica, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Glucoside, Hydroxyacetophenone, Phenoxyethanol, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Trehalose, Fragrance, Xanthan Gum, Tranexamic Acid, Disodium EDTA, Gentiana Scabra Root Extract, Tocopherol, Polysorbate 60, Sorbitan Isostearate, Phenylethyl Resorcinol, Hydroxyphenyl Propamidobenzoic Acid, Carnosine, Ascorbyl Palmitate.
protect the product from excessive heat and direct sun
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