País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Axia Medical Solutions, LLC
TOPICAL
OTC DRUG
Sunscreen • Helps prevent sunburn • Rash or irritation develops
OTC monograph final
DERMESSE SUNSCREEN SPF30- OCTINOXATE, TITANIUM DIOXIDE LOTION AXIA MEDICAL SOLUTIONS, LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- DERMESSSE SUNSCREEN SPF30 _ACTIVE INGREDIENTS_ Octinoxiate 7% w/w Titanium Dioxide 2% w/w _PURPOSE_ Sunscreen _USES:_ • Helps prevent sunburn _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 DOCTOR IF • Rash or irritation develops KEEP OUT OF REACH OF CHILDREN • If swallowed, get medical help or contact a Poison Control Center right away. SKIN CANCER/SKIN AGING ALERT: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. _DIRECTIONS_ • Apply liberally 15 minutes before sun exposure • Reapply • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours CHILDREN UNDER 6 MONTHS: Ask a doctor _INACTIVE INGREDIENTS_ Water, Aloe Barbadensis Leaf Extract, Isocetyl Stearate, Sorbitol, Cetearyl Alcohol, Ceteareth-20, Tocopheryl Acetate, Acetyl Hexapdptide-8, Hydrolyzed Rice Protein, Alcohol SDA-40, Dimethicone, Octyl Salicylate, Cety Alcohol, Methicone, Sodium Laureth Sulfate, Carbomer, Green Tea (Carnellia Sinensis) Leaf Extract, Fragrance, Triethanolamine, Stearic Acid, Lecithin, Alumina, Caprylyl Glycol, Methylisothiazolinone _OTHER INFORMATION_ _Protect this product from excessive heat and direct sun._ _QUESTIONS OR COMMENTS?_ 866-494-4466 or visit www.dermesse.com DERMESSE SUNSCREEN SPF30 octinoxate, titanium dioxide lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:68723-330 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BA Llegiu el document complet