Real Deal Foundation Fair (Titanium Dioxide) Stick [Laura Geller Make Up Inc.] -

REAL DEAL FOUNDATION FAIR (TITANIUM DIOXIDE) STICK [LAURA GELLER MAKE UP INC.]
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NDC	51389-108-11
Set ID	6b73e278-0c48-40c4-a56b-5fecd48ca821
Category	HUMAN OTC DRUG LABEL
Packager	LAURA GELLER MAKE UP INC.
Generic Name
Product Class
Product Number
Application Number	PART352

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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

FAIR

INGREDIENTS AND APPEARANCE

REAL DEAL FOUNDATION FAIR
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51389-108
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:51389-108-11	1 in 1 KIT
1		14.20 g in 1 CYLINDER

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

Labeler - LAURA GELLER MAKE UP INC. (199474524)

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

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Medic

REAL DEAL FOUNDATION FAIR (TITANIUM DIOXIDE) STICK [LAURA GELLER MAKE UP INC.]

When using this product

Stop use and ask a doctor if

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