Label: VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 12 BEIGE ROSE- titanium dioxide emulsion
VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 22 BEIGE ROSE- titanium dioxide emulsion
VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 32 BEIGE ROSE- titanium dioxide em ....... emulsion
VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 121- titanium dioxide emulsion
VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 132- titanium dioxide emulsion
VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 152- titanium dioxide emulsion
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NDC Code(s):
68745-2133-1,
68745-2133-2,
68745-2134-1,
68745-2134-2, view more68745-2135-1, 68745-2135-2, 68745-2136-1, 68745-2136-2, 68745-2137-1, 68745-2137-2, 68745-2138-1, 68745-2138-2, 68745-2139-1, 68745-2139-2, 68745-2140-1, 68745-2140-2, 68745-2141-1, 68745-2141-2, 68745-2142-1, 68745-2142-2, 68745-2143-1, 68745-2143-2, 68745-2143-3, 68745-2144-1, 68745-2144-2, 68745-2144-3, 68745-2145-1, 68745-2145-2, 68745-2145-3, 68745-2146-1, 68745-2146-2, 68745-2147-1, 68745-2147-2, 68745-2148-1, 68745-2148-2, 68745-2149-1, 68745-2149-2
- Packager: CHANEL PARFUMS BEAUTE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 8, 2023
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
- Purpose
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
-
Directions
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: Ask a doctor
- For sunscreen use:
- Other information
-
Inactive ingredients
water • methyl trimethicone • dimethicone • alcohol • silica • triethylhexanoin • butylene glycol • synthetic fluorphlogopite • isododecane • ricinus communis (castor) seed oil • acrylates/polytrimethylsiloxymethacrylate copolymer • talc • dimethicone/PEG-10/15 crosspolymer • nelumbo nucifera root water • PEG-10 dimethicone • stearic acid • alumina • potassium sorbate • fragrance • magnesium sulfate • caprylyl glycol • lauroyl lysine • triethoxycaprylylsilane • sodium hyaluronate • aluminum hydroxide • dipropylene glycol • tocopheryl acetate • pentylene glycol • laminaria digitata extract • tocopherol (may contain) ultramarines • iron oxides • titanium dioxide • mica IL57a-i
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 12 BEIGE ROSÉ
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 22 BEIGE ROSÉ
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- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 10 BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 20 BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 30 BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 40 BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 50 BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 70 BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 21 BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 60 BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 91
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 121
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 132
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - 152
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INGREDIENTS AND APPEARANCE
VITALUMIERE AQUA Â ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 12 BEIGE ROSE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2133-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2133-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 22 BEIGE ROSE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2134 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2134-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2134-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 32 BEIGE ROSE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2135 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2135-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2135-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 42 BEIGE ROSE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2136 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2136-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2136-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 52 BEIGE ROSE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2137 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2137-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2137-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 10 BEIGE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2138 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2138-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2138-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 20 BEIGE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2139 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2139-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2139-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 30 BEIGE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2140-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2140-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 40 BEIGE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2141 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2141-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2141-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 50 BEIGE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2142 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2142-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2142-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 70 BEIGE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2143-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2143-2 1 in 1 CARTON 05/22/2021 2 NDC:68745-2143-3 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 21 BEIGE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2144 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2144-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2144-2 1 in 1 CARTON 05/22/2021 2 NDC:68745-2144-3 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 60 BEIGE
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2145 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2145-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2145-2 1 in 1 CARTON 05/22/2021 2 NDC:68745-2145-3 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 91
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2146 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2146-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2146-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 121
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2147 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2147-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2147-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 132
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2148 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2148-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2148-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 VITALUMIERE AQUA  ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 152
titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2149 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  DIMETHICONE (UNII: 92RU3N3Y1O)  ALCOHOL (UNII: 3K9958V90M)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  ISODODECANE (UNII: A8289P68Y2)  CASTOR OIL (UNII: D5340Y2I9G)  TALC (UNII: 7SEV7J4R1U)  DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  STEARIC ACID (UNII: 4ELV7Z65AP)  ALUMINUM OXIDE (UNII: LMI26O6933)  POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  LAUROYL LYSINE (UNII: 113171Q70B)  TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  HYALURONATE SODIUM (UNII: YSE9PPT4TH)  ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  DIPROPYLENE GLYCOL (UNII: E107L85C40)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  LAMINARIA DIGITATA (UNII: 15E7C67EE8)  TOCOPHEROL (UNII: R0ZB2556P8)  ULTRAMARINE BLUE (UNII: I39WR998BI)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  MICA (UNII: V8A1AW0880)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2149-1 1 in 1 CARTON 05/22/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:68745-2149-2 1 in 1 CARTON 05/22/2021 2 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/22/2021 Labeler - CHANEL PARFUMS BEAUTE (275137669) Establishment Name Address ID/FEI Business Operations CHANEL PARFUMS BEAUTE 277032509 MANUFACTURE(68745-2133, 68745-2134, 68745-2135, 68745-2136, 68745-2137, 68745-2138, 68745-2139, 68745-2140, 68745-2141, 68745-2142, 68745-2143, 68745-2144, 68745-2145, 68745-2146, 68745-2147, 68745-2148, 68745-2149)