MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 CHAMOMILE- zinc oxide and titanium dioxide cream 
Jouer Cosmetics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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matte moisture tint sunscreen broard spectrum SPF 15 "Chamomile"

Unit Carton

Unit Carton

Tube

Tube

Titanium Dioxide 4.5%

Zinc Oxide 3.0%

Sunscreen

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.

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

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

protect this product from excessive heat and direct sun.

-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 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).

MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15  CHAMOMILE
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69017-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.0 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69017-204-021 in 1 BOX
1NDC:69017-204-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2014
Labeler - Jouer Cosmetics LLC (011002088)
Registrant - Jouer Cosmetics LLC (011002088)

Revised: 7/2014
Document Id: fe1cd8a0-3812-45f0-a099-12d19b738827
Set id: be1be3a1-047d-4dc9-8172-8b8123f1bc51
Version: 1
Effective Time: 20140728
 
Jouer Cosmetics LLC