AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN DEEP SAND- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN FAIR BEIGE- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN FAIR SAND (titanium dioxide and zin .......ZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN TAN SAND- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN MEDIUM NEUTRAL- titanium dioxide and zinc oxide liquid AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN MEDIUM BEIGE- titanium dioxide and zinc oxide liquid
Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen by
Drug Labeling and Warnings
Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Tarte, Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months: Ask a doctor
- Optional: apply to all skin exposed to the sun
- 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
- Other information
-
Inactive ingredients
Water, cyclopentasiloxane, octyldodecyl neopentanoate butylene glycol, polyglyceryl-4 isostearate, dimethicone crosspolymer, PEG/PPG-18/18 dimethicone, mica, dimethicone, silica, phenoxyethanol, cetyl PEG/PPG-10/1 dimethicone, stearic acid, aluminum hydroxide, sodium dehydroacetate, caprylyl glycol, phytantriol, hexyl laurate, triethoxycaprylylsilane, sodium chloride, hexylene glycol, lysine, tocopherol, tetrahexyldecyl ascorbate, nylon-12 fluorescent brightener 230 salt, polyvinylalcohol crosspolymer, kaolin, magnesium chloride, potassium chloride, zinc chloride, sodium hyaluronate, potassium sorbate, iron oxides.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Deep Sand
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Fair Beige
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Fair Sand
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Fair-Light Honey
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Ivory
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light Beige
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light Neutral
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light Sand
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light-Medium Beige
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light-Medium Honey
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light-Medium Sand
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium Honey
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium Sand
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium-Tan Honey
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Tan Honey
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Tan-Deep Sand
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Deep Honey
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Fairly Light Beige
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Fairly Light Neutral
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Light-Medium Neutral
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Rich Honey
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Tan Sand
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium Neutral
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Medium Beige
-
INGREDIENTS AND APPEARANCE
AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN DEEP SAND
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-047 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-047-01 1 in 1 CARTON 03/01/2011 1 50 mL 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 03/01/2011 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN FAIR BEIGE
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-048 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-048-01 1 in 1 CARTON 07/01/2013 1 50 mL 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 07/01/2013 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN FAIR SAND
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-049 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-049-01 1 in 1 CARTON 03/01/2011 1 50 mL 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 03/01/2011 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN FAIR- LIGHT HONEY
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-050-01 1 in 1 CARTON 07/01/2013 1 50 mL 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 07/01/2013 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN IVORY
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-051-01 1 in 1 CARTON 03/01/2011 1 50 mL 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 03/01/2011 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT BEIGE
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-052 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-052-01 1 in 1 CARTON 07/01/2013 1 50 mL 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 07/01/2013 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT NEUTRAL
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-053 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-053-01 1 in 1 CARTON 07/01/2013 1 50 mL 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 07/01/2013 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT SAND
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-054 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-054-01 1 in 1 CARTON 03/01/2011 1 50 mL 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 03/01/2011 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT-MEDIUM BEIGE
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-055 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-055-01 1 in 1 CARTON 07/01/2013 1 50 mL 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 07/01/2013 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT-MEDIUM HONEY
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-056 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-056-01 1 in 1 CARTON 03/01/2011 1 50 mL 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 03/01/2011 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT-MEDIUM SAND
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-057 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-057-01 1 in 1 CARTON 07/01/2013 1 50 mL 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 07/01/2013 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN MEDIUM HONEY
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-058 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-058-01 1 in 1 CARTON 03/01/2011 1 50 mL 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 03/01/2011 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN MEDIUM SAND
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-059 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-059-01 1 in 1 CARTON 07/01/2013 1 50 mL 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 07/01/2013 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN MEDIUM-TAN HONEY
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-060-01 1 in 1 CARTON 07/01/2013 1 50 mL 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 07/01/2013 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN TAN HONEY
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-061-01 1 in 1 CARTON 03/01/2011 1 50 mL 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 03/01/2011 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN TAN-DEEP SAND
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-062 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-062-01 1 in 1 CARTON 03/01/2011 1 50 mL 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 03/01/2011 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN DEEP HONEY
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) mica (UNII: V8A1AW0880) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-117-01 1 in 1 CARTON 07/01/2015 1 50 mL 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 07/01/2015 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN FAIRLY-LIGHT BEIGE
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-118-01 1 in 1 CARTON 07/01/2015 1 50 mL 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 07/01/2015 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN FAIRLY-LIGHT NEUTRAL
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-119-01 1 in 1 CARTON 07/01/2015 1 50 mL 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 07/01/2015 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT MEDIUM NEUTRAL
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-120-01 1 in 1 CARTON 07/01/2015 1 50 mL 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 07/01/2015 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN RICH HONEY
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-121-01 1 in 1 CARTON 07/01/2015 1 50 mL 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 07/01/2015 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN TAN SAND
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-122-01 1 in 1 CARTON 07/01/2015 1 50 mL 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 07/01/2015 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN MEDIUM NEUTRAL
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-124-01 1 in 1 CARTON 07/01/2015 1 50 mL 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 07/01/2015 AMAZONIAN CLAY 12-HOUR FULL COVERAGE FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN MEDIUM BEIGE
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 51060-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 60 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) octyldodecyl neopentanoate (UNII: X8725R883T) butylene glycol (UNII: 3XUS85K0RA) polyglyceryl-4 isostearate (UNII: 820DPX33S7) PEG/PPG-18/18 dimethicone (UNII: 9H0AO7T794) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) aluminum hydroxide (UNII: 5QB0T2IUN0) sodium dehydroacetate (UNII: 8W46YN971G) phytantriol (UNII: 8LVI07A72W) hexyl laurate (UNII: 4CG9F9W01Q) triethoxycaprylylsilane (UNII: LDC331P08E) nylon-12 (UNII: 446U8J075B) sodium chloride (UNII: 451W47IQ8X) kaolin (UNII: 24H4NWX5CO) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) zinc chloride (UNII: 86Q357L16B) lysine (UNII: K3Z4F929H6) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 51060-123-01 1 in 1 CARTON 07/01/2015 1 50 mL 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 07/01/2015 Labeler - Tarte, Inc (027905186)
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