SHISEIDO THE MAKEUP FOUNDATION  CONTROL COLOR- titanium dioxide stick 
SHISEIDO CO., LTD.

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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SHISEIDO THE MAKEUP STICK FOUNDATION Control Color

Drug Facts

Active ingredient

TITANIUM DIOXIDE 2.5％

Purpose

Sunscreen

Use

  • helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

CYCLOMETHICONE • TRIETHYLHEXANOIN • MICA • TITANIUM DIOXIDE • KAOLIN • DIMETHICONE • CERESIN • SORBITAN SESQUIISOSTEARATE • IRON OXIDES • COPERNICIA CERIFERA (CARNAUBA) WAX • EUPHORBIA CERIFERA (CANDELILLA) WAX • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • FRAGRANCE • PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE • TOCOPHEROL • TOCOPHERYL ACETATE • POLYMETHYL METHACRYLATE • SODIUM CARBONATE • ULTRAMARINES • ZINC OXIDE

Other information

  • protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

Manufactured by
SHISEIDO CO., LTD.
7-5-5 GINZA TOKYO

PRINCIPAL DISPLAY PANEL - 10 g Container Carton

SHISEIDO

The Makeup

Stick Foundation
Control Color
BROAD SPECTRUM
SPF 15
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Container Carton
SHISEIDO THE MAKEUP FOUNDATION   CONTROL COLOR
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-432
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-432-211 in 1 CARTON01/01/200112/31/2018
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200112/31/2018
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO CO., LTD.695589382MANUFACTURE(52685-432) , ANALYSIS(52685-432)

Revised: 9/2023
Document Id: 1481171e-9d8b-44a4-8f6f-25a5f8ee31cb
Set id: e64ab21e-6f0e-4793-9492-affd89ee3da0
Version: 2
Effective Time: 20230922
 
SHISEIDO CO., LTD.