Country: United States
Language: English
Source: NLM (National Library of Medicine)
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)
Webb Business Promotions
TOPICAL
OTC DRUG
Purpose Sun Screen
OTC monograph final
LIP BALM VANILLA FLAVORED- SPF 30 LIPSTICK WEBB BUSINESS PROMOTIONS _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._ ---------- SPF 30 VANILLA FAVORED LIP BALM PURPOSE PURPOSE Sun Screen DRUG FACTS Octinoxate 7.5% Homosalate 6.0% Oxybenzone 6.0% Meradimate 4.0% INACTIVE INGREDIENTS Hydrogenated Soybean Oil, Sunflower Oil, Yellow Bees Wax Pearls, Cocoa Butter, Shea Butter, Vitamin E, Aloe Vera Gel, Bacon Flavoring WARNINGS SKIN CANCER/SKIN AGING ALERT: Spending too much time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or early skin aging. FOR EXTERNAL USE ONLY. DO NOT USE on damaged or broken skin. STOP USE AND ASK DOCTOR if rash occurs. WHEN USING THIS PRODUCT keep out of eyes. KEEP OUT OF REACH OF CHILDREN. If swallowed get medical help or contact posion control center right away. DIRECTIONS Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply every 2 hours Children under 6 months : Ask a doctor STORAGE AND HANDLING INFORMATION Protect this product from excessive heat and direct sun SPF 30 NATURAL BEESWAX LIP BALM VANILLA FLAVORED DIST. BY ASI#95838 EAGAN MN 55121 MADE IN USA LIP BALM VANILLA FLAVORED spf 30 lipstick PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:70445-165 ROUTE OF ADMINISTRATION TOPICAL Webb Business Promotions ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE 4 g in 100 g INACTIVE INGREDIENTS INGREDIENT NAME STR Read the complete document