Label: SHEER FOCUS TINTED MOISTURIZER- octinoxate and zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 13, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    PRINCIPAL DISPLAY PANEL - 50 ml Carton
  • INGREDIENTS AND APPEARANCE
    SHEER FOCUS   TINTED MOISTURIZER
    octinoxate and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10348-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.8 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10348-003-011 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/FEIBusiness Operations
    ELGC Kabushiki Kaisha712808195RELABEL(10348-003) , REPACK(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(10348-003) , RELABEL(10348-003) , REPACK(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    ARAMIS, INC042918826MANUFACTURE(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636RELABEL(10348-003) , REPACK(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE787336577MANUFACTURE(10348-003) , RELABEL(10348-003) , REPACK(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL949264774MANUFACTURE(10348-003) , RELABEL(10348-003) , REPACK(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE618107429MANUFACTURE(10348-003) , RELABEL(10348-003) , REPACK(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(10348-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwest Cosmetic Laboratories LLC929572014MANUFACTURE(10348-003)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!