NDC | 69017-201-01, 69017-201-02 |
Set ID | a3df47d6-cba5-4b87-a199-00b4e441f8a8 |
Category | HUMAN OTC DRUG LABEL |
Packager | Jouer Cosmetics LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Unit Carton
- Tube
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- BOXED WARNING (What is this?)
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DOSAGE & ADMINISTRATION
Directions
apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating: Immediately after towel drying.
reapply at least every 2 hours.
Children under 6 months. Ask a doctor
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 measure including:
limit time in the sun, especially from 10 a.m. to 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
- OTHER SAFETY INFORMATION
- ADVERSE REACTIONS
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER (AQUA), CYCLOPENTASILOXANE, OCTYLDODECYL NEOPENTANOATE, BUTYLENE GLYCOL, POLYGLYCERYL-4 ISOSTEARATE, DIMETHICONE CROSSPOLYMER, PEG/PPG 18/18 DIMETHICONE, SILICA, DIMETHICONE, CETYL PEG/PPG-10/1 DIMETHICONE, STEARIC ACID, ALUMINUM HYDROXIDE, SODIUM DEHYDROACETATE, PHYTANTRIOL, HEXYL LAURATE, TRIETHOXYCAPRYLYLSILANE, NYLON-12, SODIUM CHLORIDE, RETINYL PALMITATE, TOCOPHEROL, TETRAHEXYLDECYL ASCORBATE, POLYDODECANAMIDEAMINIUM TRIAZADIPHENYLETHENESULFONATE, POLYVINYLALCOHOL CROSSPOLYMER, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, ZINC CHLORIDE, LYSINE, SODIUM HYALURONATE, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, ISOPROPYLPARABEN, POTASSIUM SORBATE. MAY CONTAIN (+/-): MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499).
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INGREDIENTS AND APPEARANCE
MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 HAZEL
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69017-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.5 mg in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 3.0 mg in 100 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) 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) 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) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) ETHYLPARABEN (UNII: 14255EXE39) BUTYLPARABEN (UNII: 3QPI1U3FV8) ISOPROPYLPARABEN (UNII: A6EOX47QK0) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69017-201-02 1 in 1 BOX 1 NDC:69017-201-01 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/01/2014 Labeler - Jouer Cosmetics LLC (011002088) Registrant - Jouer Cosmetics LLC (011002088)