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SHISEIDO REFINING MAKEUP PRIMER

Dosage form: cream
Ingredients: OCTINOXATE 1661mg in 33.9g, TITANIUM DIOXIDE 2509mg in 33.9g
Labeler: SHISEIDO AMERICA INC.
NDC Code: 52686-276

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.

SHISEIDO REFINING MAKEUP PRIMER

Drug Facts

Active ingredientsPurpose
OCTINOXATE 4.9%Sunscreen
TITANIUM DIOXIDE 7.4%Sunscreen

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

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, WATER, DIPROPYLENE GLYCOL , SILICA , GLYCERIN , POLYMETHYLSILSESQUIOXANE , POLYMETHYL METHACRYLATE , DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG-10 DIMETHICONE, DISTEARDIMONIUM HECTORITE, TRIMETHYLSILOXYSILICATE, PEG/PPG-36/41 DIMETHYL ETHER, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ALUMINUM DISTEARATE, ALUMINUM HYDROXIDE, ISOSTEARIC ACID, TRISODIUM EDTA, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, POLYSILICONE-2 , BHT, TOCOPHEROL, METHICONE, TETRADECENE, PHENOXYETHANOL, IRON OXIDES, MICA, TITANIUM DIOXIDE

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

Questions or comments?

Call toll free 1-800-906-7503

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

SHISEIDO

Refining
Makeup Primer

BROAD SPECTRUM
SPF 21
sunscreen

30mL
NET WT. 1.1 OZ.

SHISEIDO REFINING MAKEUP PRIMER 
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-276
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1661 mg  in 33.9 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2509 mg  in 33.9 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 
WATER 
TITANIUM DIOXIDE 
DIPROPYLENE GLYCOL 
SILICON DIOXIDE 
GLYCERIN 
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) 
PEG-10 DIMETHICONE (600 CST) 
ALUMINUM DISTEARATE 
ALUMINUM HYDROXIDE 
PHENOXYETHANOL 
ISOSTEARIC ACID 
TRIMETHYLSILOXYSILICATE (M/Q 0.66) 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
MICA 
EDETATE TRISODIUM 
BUTYLATED HYDROXYTOLUENE 
LAVENDER OIL 
TOCOPHEROL 
METHICONE (20 CST) 
TETRADECENE 
Packaging
#Item CodePackage Description
1NDC:52686-276-601 TUBE in 1 CARTON
133.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2010
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIOperations
SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-276), ANALYSIS(52686-276)
Establishment
NameAddressID/FEIOperations
Davlyn Industries Inc624436254MANUFACTURE(52686-276)

Revised: 06/2012
 
SHISEIDO AMERICA INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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