Country: United States
Language: English
Source: NLM (National Library of Medicine)
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Webb Candy
TOPICAL
OTC DRUG
OTC monograph final
WEBB CANDY - PEPPERMINT CANDY CANE LIP BALM LIPSTICK WEBB CANDY _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._ ---------- WEBB CANDY PEPPERMINT CANDY CANE LIP BALM Active ingredients Purpose Octyl Methoxycinnamate 7.5 percent Sunscreen Oxybenzone 3.0 percent Sunscreen Octyl Salicylate 2.0 percent Sunscreen Uses - Helps prevent sunburn - Higher SPF gives more sunburn protection - Helps prevent and temporarily protects dry, chapped or windburned lips Stop use and ask a doctor if - rash or irritation develops and lasts - condition worsens or does not improve within 7 days If swallowed, get medical help or contact a Poison Control Center right away. Directions - Apply liberally before sun exposure and as needed - Children under 6 months of age, ask a doctor Other Information Sun alert. Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Inactive Ingredients POLYBUTENE, MINERAL OIL, ETHYLHEXYL PALMITATE, PARAFFIN, CERESINE, MICROCRYSTALLINE WAX, BEES WAX, FRAGRANCE, METHYLPARABEN, PROPYLPARABEN, D AND C BLUE NO. 1 AL LAKE, TITANIUM DIOXIDE For Add'l Info Call: 1.800.999.9322 or Visit hiyamints.com or webbcandy.com WEBB CANDY peppermint candy cane lip balm lipstick Webb Candy PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:49 70 1-9 0 0 0 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 10 0 g O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y) OXYBENZONE 3 g in 10 0 g O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W) OCTISALATE 2 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH MINERAL O IL (UNII: T5L8 T28 FGP) ETHYLHEXYL PALMITATE (UNII: 28 6 Read the complete document