SHEER FOCUS TINTED MOISTURIZER- octinoxate and zinc oxide liquid

SHEER FOCUS by

Drug Labeling and Warnings

SHEER FOCUS by is a Otc medication manufactured, distributed, or labeled by SMASHBOX BEAUTY COSMETICS, INC, ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, Northwest Cosmetic Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

Apply evenly to face prior to sun exposure.

ACTIVE INGREDIENTS

7.0% Octinoxate (2-Ethylhexyl Methoxycinnamate), 2.9% Zinc Oxide.

OTHER INGREDIENTS

Water (Aqua) (Eau), Phenyl Trimethicone, Hydrogenated Polyisobutene, Butylene Glycol, C12-15 Alkyl Benzoate, Potassium Cetyl Phosphate, Acrylates Copolymer, Caprylyl Glycol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyltaurate Copolymer, Polysorbate 60, Squalane, Honey (Mel) (Miel), Pectin, Lecithin, C20-22 Alcohols, C20-22 Alkyl Phosphate, Glyceryl Stearate, PEG 100 Stearate, Polysilicone-11, Phenoxyethanol, Dimethicone, Oligopeptide-10, Silica, Betaine, Hydrogenated Lecithin, Tetrahexyldecyl Ascorbate, Ethoxydiglycol, Xanthan Gum, Polyhydroxystearic Acid, Propylene Glycol Stearate, Triethanolamine, Triethoxy Caprylylsilane, Polysorbate 20, Sorbitan Laurate, Tocopheryl Acetate, Glycerin, Propylene Glycol Laurate, Sodium Dehydroacetate, Tetrasodium EDTA. May Contain/Peut Contenir: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499).

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.

Keep out of reach of children. Children under six months of age: ask doctor.

SPL UNCLASSIFIED SECTION

Sun alert: The sun may cause sunburn, premature ageing of skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

SPL UNCLASSIFIED SECTION

Dist. Smashbox Beauty Cosmetics, Inc.
Culver City, CA 90232
Northampton, NN1 2QZ,United Kingdom

PRINCIPAL DISPLAY PANEL - 50 ml Carton

SELF
HEALTHY
beauty
AWARD
WINNER
2009

smashbox

SHEER FOCUS
TINTED MOISTURIZER

WITH UVA/UVB SPF 15
OIL-FREE

1.7 fl. oz. US. e 50 ml
DIN 02307081

INGREDIENTS AND APPEARANCE

SHEER FOCUS   TINTED MOISTURIZER
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.8 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Butylene Glycol (UNII: 3XUS85K0RA)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Caprylyl Glycol (UNII: 00YIU5438U)
Polysorbate 60 (UNII: CAL22UVI4M)
Squalane (UNII: GW89575KF9)
Honey (UNII: Y9H1V576FH)
Pectin (UNII: 89NA02M4RX)
C20-22 Alcohols (UNII: O4M0347C6A)
C20-22 Alkyl Phosphate (UNII: L4VKP0Y7RP)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Dimethicone (UNII: 92RU3N3Y1O)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Betaine (UNII: 3SCV180C9W)
Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Xanthan Gum (UNII: TTV12P4NEE)
Trolamine (UNII: 9O3K93S3TK)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sorbitan Monolaurate (UNII: 6W9PS8B71J)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Glycerin (UNII: PDC6A3C0OX)
Sodium Dehydroacetate (UNII: 8W46YN971G)
Edetate Sodium (UNII: MP1J8420LU)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10348-003-01	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2011

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL(10348-003) , REPACK(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(10348-003) , RELABEL(10348-003) , REPACK(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	RELABEL(10348-003) , REPACK(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE(10348-003) , RELABEL(10348-003) , REPACK(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE(10348-003) , RELABEL(10348-003) , REPACK(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE(10348-003) , RELABEL(10348-003) , REPACK(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(10348-003)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Laboratories LLC		929572014	MANUFACTURE(10348-003)