Label: UNID PHYSICAL SUN- titanium dioxide lotion

  • NDC Code(s): 83119-243-50
  • Packager: Sage Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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  • Active Ingredients

    Titanium Dioxide   11.3%

  • Purpose

    Sunscreen

  • Uses

    HVA / UVB protection

    • Tear-free formula
    • Paraben free
    • Hypoallergenic
    • Fragrance free
  • Directions

    Apply an appropriate amount to the face and body prior to sun exposure, then pat lightly on the area. Reapply as needed.

  • Cautions

    External use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • STOP USE

    Avoid contact with eyes. In case of severe irritation, stop usage immediately and consult a doctor.

  • Storage

    Store in a cool, dry place away from heat and direct sunlight.

  • SPL UNCLASSIFIED SECTION

    Sage Pharmaceuticals Inc

    Product of Taiwan

    Manufactured for IDAQS Biotech, Inc.

    Distributed by Beauty River International Inc.
    901 S. Fremont Ave 108, Alhambra, CA 91803-4703, USA

  • Inactive Ingredients

    WATER, TRISILOXANE, PEG-6 CAPRYLIC/CAPRIC GLYCERIDES, COCO-CAPRYLATE/CAPRATE, GLYCERYL STEARATE CITRATE, PENTYLENE GLYCOL,
    DIMETHICONE, SILICON DIOXIDE, TREHALOSE, PROPANEDIOL, SODIUM ACRYLATES CROSSPOLYMER-2, 1,2-HEXANEDIOL, XANTHAN GUM, BUTYLENE GLYCOL, LECITHIN, SUNFLOWER, DISODIUM GLYCYRRHIZATE, CAPRYLHYDROXAMIC ACID, MEDICAGO SATIVA WHOLE

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    UNID PHYSICAL SUN 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83119-243
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE11.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    DISODIUM GLYCYRRHIZATE (UNII: L8Q0US0J7V)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83119-243-501 in 1 PACKAGE11/28/2022
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM020.1011/28/2022
    Labeler - Sage Pharmaceuticals Inc (656245476)
    Registrant - Sage Pharmaceuticals Inc (656245476)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sage Pharmaceuticals Inc656245476manufacture(83119-243)
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