SHEER DEFENSE TINTED MOISTURIZER BROAD SPECTRUM SPF 15 M50 MERLE NORMAN- octinoxate, titanium dioxide liquid

Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 M50 by

Drug Labeling and Warnings

Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 M50 by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Octinoxate7.5% Sunscreen

Titanium Dioxide 4.19% 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.

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

Stop use and ask a doctor if rash occurs

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.

Directions

For sunscreen use

apply liberally and evenly 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 value of 15 or higher and other sun protection measures including:

limiting time in the sun, especially from 10 a.m. - 2p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months: ask a doctor

Inactive ingredients:

Water (Aqua), Dimethicone, Butylene Glycol, Glyceryl Stearate SE, Mica, Talc, Iron Oxides, Glyceryl Dilaurate, Glyceryl Behenate, Ceramide 3, Saccharide Isomerate, Allantoin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Glycine Soja (Soybean) Germ Extract, Echinacea Purpurea Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Equisetum Arvense Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Oleifera Leaf Extract, Lecithin, Petrolatum, Palmitic Acid, Polyglyceryl-10 Decaoleate, Polyacrylamide, PEG-12 Dimethicone, octyldodecyl Stearoyl Stearate, Steareth-20, C13-14 Isoparaffin, Isocetyl Alcohol, Propylene Glycol, Laureth-7, Silica, Cyclodextrin, Disodium EDTA, Phenoxyethanol, Tetrasodium EDTA, BHT, Diazolidinyl Urea, Fragrance (Parfum)

PRINCIPAL DISPLAY PANEL

Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15

M50

Merle Norman

Established in Los Angeles since 1931

35 g Net Wt. 1.25 Oz.

INGREDIENTS AND APPEARANCE

SHEER DEFENSE TINTED MOISTURIZER BROAD SPECTRUM SPF 15 M50  MERLE NORMAN
octinoxate, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.19 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
CERAMIDE 3 (UNII: 4370DF050B)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SOYBEAN GERM (UNII: JBW2VHD14M)
ECHINACEA PURPUREA (UNII: QI7G114Y98)
FENNEL SEED (UNII: G3QC02NIE6)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PETROLATUM (UNII: 4T6H12BN9U)
PALMITIC ACID (UNII: 2V16EO95H1)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
STEARETH-20 (UNII: L0Q8IK9E08)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOCETYL ALCOHOL (UNII: 1800H64066)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LAURETH-7 (UNII: Z95S6G8201)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-153-02	1 in 1 CARTON	12/10/2012
1	NDC: 57627-153-01	35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/10/2012

Labeler - Merle Norman Cosmetics, Inc. (008479388)

Registrant - Merle Norman Cosmetics, Inc. (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics, Inc.		008479388	manufacture(57627-153)