Label: GLYTONE RETEXTURIZE BODY- octinoxate, octisalate, oxybenzone lotion

  • 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 February 1, 2011

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

View All Sections
  • WARNINGS



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



    Inactive Ingredients Water (aqua), Glycolic Acid, C12-15 Alkyl Benzoate, Cyclomethicone, Glyceryl Stearate, Glycerin, Ammonium Hydroxide, PEG-150 Stearate, Polyacrylamide, Cetyl Alcohol, Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter), Cholesterol, Phenozyethanol, Dimethiconol, C13-14 Isoparafin, Methylparaben, Xanthan gum, cetearyl glucoside, disodium EDTA, tocopheryl acetate, laureth-7

  • INDICATIONS & USAGE



    Uses

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection
    • Provides moderate protection against sunburn.
  • ACTIVE INGREDIENT

    Active Ingredients                                 Purpose

    Octinoxate 7.5%                                       Sunscreen

    Octisalate 5.0%                                         Sunscreen

    Oxbenzone 3.0%                                       Sunscreen

  • DOSAGE & ADMINISTRATION



    Directions

    • Apply daily to cleansed body skin or as directed by your physician; avoid face
    • Apply generously before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
  • INFORMATION FOR PATIENTS



    Other Information

    Sun alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin cancer and harmful effects of the sun. This product is ot intended for sunbathing.

  • PRINCIPAL DISPLAY PANEL

    label


    Glytone retexturize body lotion

    SPF 15

    Glycolic complex

    250 ml e/ 8.4 fl. oz.

  • PURPOSE

    Purpose   sunscreen
  • KEEP OUT OF REACH OF CHILDREN



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

  • INGREDIENTS AND APPEARANCE
    GLYTONE RETEXTURIZE BODY 
    octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate18.75 mL  in 250 mL
    octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate12.5 mL  in 250 mL
    oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone7.5 mL  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIA (UNII: 5138Q19F1X)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    LAURETH-7 (UNII: Z95S6G8201)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-208-011 in 1 BOX
    1250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/19/2010
    Labeler - Glytone (117196928)
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!