Country: United States
Language: English
Source: NLM (National Library of Medicine)
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Exelencia Importers Corp
TOPICAL
OTC DRUG
Uses - Helps Prevent Sunburn Stop use and ask a doctor if rash occurs
OTC monograph final
SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE- OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE CREAM EXELENCIA IMPORTERS CORP _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._ ---------- EXEL CLARIFYING SPF 30 PLUS Active ingredients Purpose Octocrylene 5% Sunscreen Octinoxate 7.5% Sunscreen Octisalate 5% Sunscreen Oxybenzone 3% Sunscreen Titanium Dioxide 3% Sunscreen Uses Helps Prevent Sunburn Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if rash occurs Warnings 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. 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 Directions Apply liberally 15 minutes before sun exposure Reapply: At least every 2 hours Children under 6 months ask doctor WATER, PROPYLENE GLYCOL, GLYCERIN, GLYCERYL STEARATE, CETYL ALCOHOL, STEARIC ACID, DIMETHICONE, ALOE VERA LEAF, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, POLYSORBATE-20, DMDM HYDANTOIN, METHYLPARABEN, PROPYLPARABEN, IRON OXIDE CI 77491, CI 77492, CI 77499, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SHEA BUTTER, XANTHAN GUM, TOCOPHERYL ACETATE, TRIETHANOLAMINE, FRAGRANCE, BHT Exel Clarifying Line High Sun Protection Creme SPF 30 PLUS for use in "Exel Clarifying program" 3.30 fl. oz SUN PROTECTION CREME SPF 30 PLUS EXEL CLARIFYING LINE octocrylene, octinoxate, octisalate, oxybenzone, titanium dioxide cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:538 6 3-122 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH O CTO CRYLENE (UNII: 5A6 8 WG Read the complete document