Real Deal Foundation MEDIUM

Dosage form: stick
Ingredients: OCTINOXATE 7g in 100g, OXYBENZONE 3g in 100g, TITANIUM DIOXIDE 5g in 100g
Labeler: LAURA GELLER MAKE UP INC.
NDC Code: 51389-110

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.

Drug Facts

Active Ingredients

Octinoxate 7%
Oxybenzone 3%
Titanium Dioxide 5%

Purpose

Sunscreen

Use
  • Higher SPF gives more sunburn protection.
  • Provides moderate protection against sunburn.

Warnings

For external use only.

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

Stop use and ask a doctor if
  • Rash or irritation develops and lasts.
               You may report side effect to FDA at 1-800-FDA-1088.

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

Directions
  • Apply evenly before sun exposure as needed.
  • Children under 6 months of age: ask a doctor.

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Silica, Cetyl Dimethicone, Beeswax, Octyldodecyl Neopentanoate, Euphorbia Cerifera (Candelilla) Wax, Propylene Glycol Laurate, Polyethylene, Nylon-12, VP/Hexadecene Copolymer,Octyldodecanol, Ethylhexylglycerin, Cetyl Palmitate, Tocopherol, Tocopheryl Acetate, Ascorbyl Palmitate, Cantella Asiatica Extract, Camellia Sinensis Leaf Extract, Sorbitan Sesquioleate, Water, Phenoxyethanol, Caprylyl Glycol, Hexylene Glycol. May Contain: Mica, Titanium Dioxide, Iron Oxides.

Questions?

Call Laura Geller Make-up, Inc., 1(800) MAKE UP4

Principal Display PanelLAURA GELLER

BEAUTY INGENUITY

real deal duo

Real Deal
Foundation Stick SPF 15

Net. Wt. 0.50 oz. / 14.20 g

&

Real Deal Concealer

Net. Wt. 0.70 oz. / 20 g / 16.39 ml

MEDIUM
REAL DEAL FOUNDATION  MEDIUM
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51389-110
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE3 g  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES 
ETHYLHEXYL PALMITATE 
SILICON DIOXIDE 
YELLOW WAX 
OCTYLDODECYL NEOPENTANOATE 
CANDELILLA WAX 
PROPYLENE GLYCOL LAURATES 
HIGH DENSITY POLYETHYLENE 
OCTYLDODECANOL 
ETHYLHEXYLGLYCERIN 
CETYL PALMITATE 
TOCOPHEROL 
ALPHA-TOCOPHEROL ACETATE 
ASCORBYL PALMITATE 
CENTELLA ASIATICA 
GREEN TEA LEAF 
SORBITAN SESQUIOLEATE 
WATER 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
HEXYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:51389-110-111 CYLINDER (CYLINDER) in 1 KIT
114.20 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/13/2011
Labeler - LAURA GELLER MAKE UP INC. (199474524)
Establishment
NameAddressID/FEIOperations
MANA PRODUCTS, INC078870292manufacture

Revised: 11/2011
 
LAURA GELLER MAKE UP 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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