Label: SOFTLIPS VANILLA WATERMELON- dimethicone, octinoxate, octisalate, oxybenzone stick
- NDC Code(s): 10742-8478-1
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 7, 2023
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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
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INGREDIENTS AND APPEARANCE
SOFTLIPS VANILLA WATERMELON
dimethicone, octinoxate, octisalate, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8478 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 30 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 g Inactive Ingredients Ingredient Name Strength CERESIN (UNII: Q1LS2UJO3A) SQUALANE (UNII: GW89575KF9) ETHYLHEXYL PALMITATE (UNII: 2865993309) PETROLATUM (UNII: 4T6H12BN9U) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) MYRISTYL LACTATE (UNII: 1D822OC34X) CETYL ALCOHOL (UNII: 936JST6JCN) MYRISTYL LAURATE (UNII: 58U0NZN2BT) MYRISTYL ALCOHOL (UNII: V42034O9PU) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LEVOMENTHOL (UNII: BZ1R15MTK7) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8478-1 3 in 1 BLISTER PACK 06/01/2020 1 2 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2020 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-8478)