Label: SOFTLIPS CHERRY CORDIAL, MAPLE BUTTER, FROSTED BERRY- dimethicone, octinoxate, octisalate, oxybenzone stick
- NDC Code(s): 10742-7001-3
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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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- Active ingredient
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INGREDIENTS AND APPEARANCE
SOFTLIPS CHERRY CORDIAL, MAPLE BUTTER, FROSTED BERRY
dimethicone, octinoxate, octisalate, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-7001 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 ug 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) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-7001-3 3 in 1 BLISTER PACK 10/15/2018 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 final part352 10/15/2018 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-7001)