Label: GLOVES IN A BOTTLE WITH SPF15- octinoxate, octisalate, homosalate lotion

  • NDC Code(s): 69081-002-05, 69081-002-08, 69081-002-13, 69081-002-18
  • Packager: Gloves in a Bottle, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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

  • ACTIVE INGREDIENTS

    Octinoxate  7%

    Octisalate  5%

    Homosalate  3%

  • OTC - PURPOSE SECTION

    Sunscreen

  • USES

    Helps prevent sunburn.

  • WARNINGS

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin 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 doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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

  • DIRECTIONS

    Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

  • INACTIVE INGREDIENTS

    Water (Aqua), Aloe Vera Leaf Extract , Cyclopentasiloxane, Dimethicone, Methyl Gluceth-20, Symphytum Officinale Leaf (Comfrey), Chamomilla Recutita (Matricaria Chamomile), Achillea Millefolium (Yarrow), Chondrus Crispus (Carrageenan), Tocopheryl Acetate (Vitamin E), Sorbitan Monoleate, 1,2 Hexanediol, Caprylyl Gylcol, Butylene Glycol, Aminomethyl Propanol, Phenoxyethanol (preservative), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-Hydroxyethoxypropyl Dimethicone.

  • OTHER INFORMATION

    PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

  • QUESTIONS OR COMMENTS?

    Call toll free 1-800-600-1881

  • PRINCIPAL DISPLAY PANEL

    8 oz GIAB spf yellow_pr4

  • INGREDIENTS AND APPEARANCE
    GLOVES IN A BOTTLE WITH SPF15 
    octinoxate, octisalate, homosalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69081-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69081-002-08244.94 g in 1 BOTTLE; Type 0: Not a Combination Product07/07/2014
    2NDC:69081-002-13100 g in 1 TUBE; Type 0: Not a Combination Product02/07/2017
    3NDC:69081-002-055 g in 1 PACKAGE; Type 0: Not a Combination Product09/27/2019
    4NDC:69081-002-18240 g in 1 TUBE; Type 0: Not a Combination Product02/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/07/2014
    Labeler - Gloves in a Bottle, Inc (926499054)