Label: LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 1/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 2/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 3/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 4/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 5/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 6/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 7/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 OBSCURE 8/BEIGE- titanium dioxide and zinc oxide powder
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 OBSCURE 9/BEIGE- titanium dioxide and zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 43596-0090-1, 43596-0090-2, 43596-0090-3, 43596-0090-4, view more43596-0091-1, 43596-0091-2, 43596-0091-3, 43596-0091-4, 43596-0092-1, 43596-0092-2, 43596-0092-3, 43596-0092-4, 43596-0093-1, 43596-0093-2, 43596-0093-3, 43596-0093-4, 43596-0094-1, 43596-0094-2, 43596-0094-3, 43596-0094-4, 43596-0095-1, 43596-0095-2, 43596-0095-3, 43596-0095-4, 43596-0096-1, 43596-0096-2, 43596-0096-3, 43596-0096-4, 43596-0097-1, 43596-0097-2, 43596-0097-3, 43596-0097-4, 43596-0098-1, 43596-0098-2, 43596-0098-3, 43596-0098-4 - Packager: Ventura Corporation LTD
- 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 September 27, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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INACTIVE INGREDIENTS
MICA, DIMETHICONE, POLYMETHYLSILSESQUIOXANE, ZINC STEARATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PERFLUOROOCTYL TRIETHOXYSILANE, TOCOPHERYL ACETATE, HYDROGEN DIMETHICONE, PHENOXYETHANOL, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINA, HEXYL LAURATE, FRAGRANCE, CAPRYLYL GLYCOL, CRITHMUM MARITIMUM EXTRACT, TRIETHOXYCAPRYLYLSILANE, CHLORPHENESIN, CERAMIDE 3, BUTYLPHENYL METHYLPROPIONAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, HYDROXYCITRONELLAL, CITRONELLOL, GERANIOL, d-LIMONENE, ALPHA-ISOMETHYL IONONE. MAY CONTAIN: IRON OXIDES, TITANIUM DIOXIDE.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 1/Beige
- PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 2/Beige
- PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 3/Beige
- PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 4/Beige
- PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 5/Beige
- PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 6/Beige
- PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 7/Beige
- PRINCIPAL DISPLAY PANEL - 10 g Container Box - Obscure 8/Beige
- PRINCIPAL DISPLAY PANEL - 10 g Container Box - Obscure 9/Beige
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INGREDIENTS AND APPEARANCE
LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 Â CLAIRE 1/BEIGE
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0090 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0575 g  in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.049 g  in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880)  DIMETHICONE (UNII: 92RU3N3Y1O)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  ZINC STEARATE (UNII: H92E6QA4FV)  HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  ALUMINUM OXIDE (UNII: LMI26O6933)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  GERANIOL (UNII: L837108USY)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0090-2 1 in 1 BOX 08/18/2018 1 NDC:43596-0090-1 12 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43596-0090-4 1 in 1 BOX 08/18/2018 2 NDC:43596-0090-3 10 g in 1 CONTAINER; 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 08/18/2018 LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15  CLAIRE 2/BEIGE
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0091 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0575 g  in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.049 g  in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880)  DIMETHICONE (UNII: 92RU3N3Y1O)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  ZINC STEARATE (UNII: H92E6QA4FV)  HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  ALUMINUM OXIDE (UNII: LMI26O6933)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  GERANIOL (UNII: L837108USY)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0091-2 1 in 1 BOX 08/18/2018 1 NDC:43596-0091-1 12 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43596-0091-4 1 in 1 BOX 08/18/2018 2 NDC:43596-0091-3 10 g in 1 CONTAINER; 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 08/18/2018 LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15  CLAIRE 3/BEIGE
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0092 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0575 g  in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.049 g  in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880)  DIMETHICONE (UNII: 92RU3N3Y1O)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  ZINC STEARATE (UNII: H92E6QA4FV)  HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  ALUMINUM OXIDE (UNII: LMI26O6933)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  GERANIOL (UNII: L837108USY)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0092-2 1 in 1 BOX 08/18/2018 1 NDC:43596-0092-1 12 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43596-0092-4 1 in 1 BOX 08/18/2018 2 NDC:43596-0092-3 10 g in 1 CONTAINER; 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 08/18/2018 LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15  CLAIRE 4/BEIGE
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0093 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0575 g  in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.049 g  in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880)  DIMETHICONE (UNII: 92RU3N3Y1O)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  ZINC STEARATE (UNII: H92E6QA4FV)  HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  ALUMINUM OXIDE (UNII: LMI26O6933)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  GERANIOL (UNII: L837108USY)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0093-2 1 in 1 BOX 08/18/2018 1 NDC:43596-0093-1 12 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43596-0093-4 1 in 1 BOX 08/18/2018 2 NDC:43596-0093-3 10 g in 1 CONTAINER; 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 08/18/2018 LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15  MEDIUM 5/BEIGE
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0094 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0575 g  in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.049 g  in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880)  DIMETHICONE (UNII: 92RU3N3Y1O)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  ZINC STEARATE (UNII: H92E6QA4FV)  HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  ALUMINUM OXIDE (UNII: LMI26O6933)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  GERANIOL (UNII: L837108USY)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0094-2 1 in 1 BOX 08/18/2018 1 NDC:43596-0094-1 12 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43596-0094-4 1 in 1 BOX 08/18/2018 2 NDC:43596-0094-3 10 g in 1 CONTAINER; 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 08/18/2018 LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15  MEDIUM 6/BEIGE
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0095 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0575 g  in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.049 g  in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880)  DIMETHICONE (UNII: 92RU3N3Y1O)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  ZINC STEARATE (UNII: H92E6QA4FV)  HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  ALUMINUM OXIDE (UNII: LMI26O6933)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  GERANIOL (UNII: L837108USY)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0095-2 1 in 1 BOX 08/18/2018 1 NDC:43596-0095-1 12 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43596-0095-4 1 in 1 BOX 08/18/2018 2 NDC:43596-0095-3 10 g in 1 CONTAINER; 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 08/18/2018 LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15  MEDIUM 7/BEIGE
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0096 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0575 g  in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.049 g  in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880)  DIMETHICONE (UNII: 92RU3N3Y1O)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  ZINC STEARATE (UNII: H92E6QA4FV)  HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  ALUMINUM OXIDE (UNII: LMI26O6933)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  GERANIOL (UNII: L837108USY)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0096-2 1 in 1 BOX 08/18/2018 1 NDC:43596-0096-1 12 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43596-0096-4 1 in 1 BOX 08/18/2018 2 NDC:43596-0096-3 10 g in 1 CONTAINER; 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 08/18/2018 LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15  OBSCURE 8/BEIGE
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0097 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0575 g  in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.049 g  in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880)  DIMETHICONE (UNII: 92RU3N3Y1O)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  ZINC STEARATE (UNII: H92E6QA4FV)  HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  ALUMINUM OXIDE (UNII: LMI26O6933)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  GERANIOL (UNII: L837108USY)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0097-2 1 in 1 BOX 08/18/2018 1 NDC:43596-0097-1 12 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43596-0097-4 1 in 1 BOX 08/18/2018 2 NDC:43596-0097-3 10 g in 1 CONTAINER; 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 08/18/2018 LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15  OBSCURE 9/BEIGE
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0098 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0575 g  in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.049 g  in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880)  DIMETHICONE (UNII: 92RU3N3Y1O)  POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  ZINC STEARATE (UNII: H92E6QA4FV)  HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  ALUMINUM OXIDE (UNII: LMI26O6933)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  GERANIOL (UNII: L837108USY)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0098-2 1 in 1 BOX 08/18/2018 1 NDC:43596-0098-1 12 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43596-0098-4 1 in 1 BOX 08/18/2018 2 NDC:43596-0098-3 10 g in 1 CONTAINER; 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 08/18/2018 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(43596-0090, 43596-0091, 43596-0092, 43596-0093, 43596-0094, 43596-0095, 43596-0096, 43596-0097, 43596-0098)
