Label: SOFTLIPS PEARL PLUS VANILLA- dimethicone, octinoxate, octisalate, oxybenzone kit
- NDC Code(s): 10742-7011-1
- 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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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
Skin Cancer/Skin Agent 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
- Dosage and Administration
- Other information
-
Inactive ingredients
lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecane copolymer, mineral oil, bis-diglycerl polyacyladipate-2, oleyl alcohol, copernicia cerifera (carnauba) wax, ricinus communis (castor) seed oil, cetyl lactate, polyethylene, paraffin, ammonium glycyrrhizate, BHT, flavor, magnesium stearate, menthol, tocopheryl acetate [vitamin E], bismuth oxychloride, carmine, mica, titanium dioxide
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
-
Warnings
Skin Cancer/Skin Agent 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
- Dosage and Administration
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SOFTLIPS PEARL PLUS VANILLA
dimethicone, octinoxate, octisalate, oxybenzone kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-7011 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-7011-1 1 in 1 PACKAGE; Type 0: Not a Combination Product 01/02/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CYLINDER 1 g Part 2 1 CYLINDER 1 g Part 1 of 2 SOFTLIPS PEARL
octinoxate, octisalate stickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength LANOLIN OIL (UNII: OVV5IIJ58F) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) CERESIN (UNII: Q1LS2UJO3A) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) MINERAL OIL (UNII: T5L8T28FGP) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) OLEYL ALCOHOL (UNII: 172F2WN8DV) CARNAUBA WAX (UNII: R12CBM0EIZ) CASTOR OIL (UNII: D5340Y2I9G) CETYL LACTATE (UNII: A7EVH2RK4O) PARAFFIN (UNII: I9O0E3H2ZE) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MAGNESIUM STEARATE (UNII: 70097M6I30) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) CARMINIC ACID (UNII: CID8Z8N95N) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 g in 1 CYLINDER; 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 02/01/2010 Part 2 of 2 SOFTLIPS VANILLA
dimethicone, octinoxate, octisalate, oxybenzone stickProduct Information 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) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 g in 1 CYLINDER; 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 11/19/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/02/2017 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-7011)
