REAL DEAL FOUNDATION MEDIUM- titanium dioxide stick

Real Deal Foundation by

Drug Labeling and Warnings

Real Deal Foundation by is a Otc medication manufactured, distributed, or labeled by LAURA GELLER MAKE UP INC., MANA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Panel

LAURA 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

INGREDIENTS AND APPEARANCE

REAL DEAL FOUNDATION  MEDIUM
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51389-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
YELLOW WAX (UNII: 2ZA36H0S2V)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CANDELILLA WAX (UNII: WL0328HX19)
PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
TOCOPHEROL (UNII: R0ZB2556P8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51389-110-11	1 in 1 KIT
1		14.20 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/13/2011

Labeler - LAURA GELLER MAKE UP INC. (199474524)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		078870292	manufacture