Medication Guide App

SHEER FOCUS TINTED MOISTURIZER

Dosage form: liquid
Ingredients: OCTINOXATE 7mL in 100mL, ZINC OXIDE 2.8mL in 100mL
Labeler: SMASHBOX BEAUTY COSMETICS, INC
NDC Code: 10348-003

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.

SHEER FOCUS
TINTED MOISTURIZER

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.

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.

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

SHEER FOCUS   TINTED MOISTURIZER
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10348-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE2.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Phenyl Trimethicone 
Butylene Glycol 
Alkyl (C12-15) Benzoate 
Potassium Cetyl Phosphate 
Caprylyl Glycol 
Polysorbate 60 
Squalane 
Honey 
Pectin 
C20-22 Alcohols 
C20-22 Alkyl Phosphate 
Glyceryl Monostearate 
Peg-100 Stearate 
Phenoxyethanol 
Dimethicone 
Silicon Dioxide 
Betaine 
Hydrogenated Soybean Lecithin 
Tetrahexyldecyl Ascorbate 
Diethylene Glycol Monoethyl Ether 
Xanthan Gum 
Trolamine 
Triethoxycaprylylsilane 
Polysorbate 20 
Sorbitan Monolaurate 
Alpha-Tocopherol Acetate 
Glycerin 
Sodium Dehydroacetate 
Edetate Sodium 
Ferric Oxide Red 
Ferric Oxide Yellow 
Ferrosoferric Oxide 
Titanium Dioxide 
Packaging
#Item CodePackage Description
1NDC:10348-003-011 TUBE (TUBE) in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/2011
Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
Establishment
NameAddressID/FEIOperations
ELGC Kabushiki Kaisha712808195RELABEL(10348-003), REPACK(10348-003)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(10348-003), RELABEL(10348-003), REPACK(10348-003)
Establishment
NameAddressID/FEIOperations
ARAMIS, INC042918826MANUFACTURE(10348-003)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636RELABEL(10348-003), REPACK(10348-003)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(10348-003)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(10348-003)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(10348-003)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(10348-003)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(10348-003)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE787336577MANUFACTURE(10348-003), RELABEL(10348-003), REPACK(10348-003)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL949264774MANUFACTURE(10348-003), RELABEL(10348-003), REPACK(10348-003)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE618107429MANUFACTURE(10348-003), RELABEL(10348-003), REPACK(10348-003)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(10348-003)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(10348-003)
Establishment
NameAddressID/FEIOperations
Northwest Cosmetic Laboratories LLC929572014MANUFACTURE(10348-003)

Revised: 01/2012
 
SMASHBOX BEAUTY COSMETICS, 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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