MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 HAZEL- zinc oxide and titanium dioxide cream

MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by Jouer Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Unit Carton

Tube

ACTIVE INGREDIENT

Titanium Dioxide 4.5%

Zinc Oxide 3.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Uses

Helps prevent sunburns

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.

BOXED WARNING

(What is this?)

Warnings

Warnings

For external use only

Do not use on damages or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

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

protect this product from excessive heat and direct sun.

ADVERSE REACTIONS

-you may report a serious adverse reaction to Jouer Customer support, toll free: 1-800-315-5374, M-F, 8am-6pm PST (US and Canada Only)

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).

INGREDIENTS AND APPEARANCE

MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15  HAZEL
zinc oxide and titanium dioxide cream

Product 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)