Label: BURBERRY FRESH GLOW FOUNDATION LUMINOUS FLUID BEIGE NO. 26- octinoxate cream

  • 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 September 18, 2019

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

View All Sections
  • Drug facts


  • Active Ingredients

    Octinoxate 7%

    Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn.

  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and earlyskin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging  

    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.

    Stop use and ask a doctor

    • If rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 mins before sun exposure.
    • Reapply at least every 2 hrs.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    water, dimethicone, cyclopentasiloxane, peg-10 dimethicone, propanediol, aluminium starch octenylsuccinate, mica, phenoxyethanol, sodium chloride, disteardimonium hectorite, disodium stearoyl glutamate, dimethicone crosspolymer, tocopheryl acetate, ethylhexylglycerin, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, hexyl laurate, alcohol denat. (sd alcohol 40-b), tea (camellia sinensis) leaf extract, caprylic/capric triglyceride, panthenol, glycerin, sodium hyaluronate, aluminium hydroxide, BHT, spanish lavender (lavandula stoechas) extract, dog rose (rosa canina) fruit extract, pantolactone, phenethyl alcohol, tocopherol, pantaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, rutin, titanium dioxide, iron oxides.

  • SPL UNCLASSIFIED SECTION

    Manufactured for Burberry Limited  Horseferry House  Horseferry Road  London SW1P2AW  Made In France  Burberry.com

    You May Report Serious  Adverse Events to: 444 Madison Avenue  New York, NY 10022

  • PRINCIPAL DISPLAY PANEL

    Beige No.26  BURBERRY  FRESH GLOW FOUNDATION   LUMINOUS FLUID FOUNDATION  SUNSCREEN BROAD SPECTRUM SPF 12   1 FL OZ  (30 ML)

  • Product Label

    Beige No 26

  • INGREDIENTS AND APPEARANCE
    BURBERRY FRESH GLOW FOUNDATION LUMINOUS FLUID BEIGE NO. 26 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69038-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    RUTIN (UNII: 5G06TVY3R7)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PANTOLACTONE, (R)- (UNII: J288D7O0JS)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MICA (UNII: V8A1AW0880)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    TEA LEAF (UNII: GH42T47V24)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69038-005-001 in 1 CARTON11/14/2014
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69038-005-013 in 1 BOX11/14/2014
    21 in 1 CARTON
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/14/2014
    Labeler - Burberry Limited (210047627)
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!