EX-GLOW-SION SPF-20 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]

EX-GLOW-SION SPF-20 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]
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NDC 69863-103-11, 69863-103-12, 69863-103-51
Set ID 0cd85bfd-cb91-48d4-8dd2-d59be19a130e
Category HUMAN OTC DRUG LABEL
Packager HATCHBEAUTY PRODUCTS LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENTS

    TITANIUM DIOXIDE 5.75%

    ZINC OXIDE 3.70%

  • PURPOSE

    SUNSCREEN

  • USES

    HELPS PREVENT SUNBURN

  • WARNINGS

    • 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

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

  • Directions

    • Shake well before use
    • Apply generously to face 15 minutes before sun exposure.
    • Children under 6 months of age: ask a doctor.
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

          • limit time in the sun, especially from 10 a.m. – 2 p.m.
          • wear long-sleeved shirts, pants, hats and sunglasses.
          • Reapply at least every 2 hours.
          • Use a water resistant sunscreen if swimming or sweating; immediately after towel drying.

  • Inacitve Ingredients

    Water/Aqua/Eau, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, Propylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone,  Isononyl Isononanoate, Silica, Butylene Glycol, Trimethylsiloxysilicate, Argania Spinosa Kernel Oil, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Alcohol Denat., Quaternium-18 Hectorite, Glycerin, Prunus Persica (Peach) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Oenothera Biennis (Evening Primrose) Flower/Leaf/Stem Extract, Jasminum Officinale (Jasmine) Flower Extract, Amaranthus Caudatus Seed Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Ceramide 3, Niacinamide, Bisabolol, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Sodium Chloride, Xanthan Gum, Sucrose Palmitate, Maltodextrin, Perfluorodecalin, Pyridoxine HCl, Calcium Pantothenate, Synthetic Fluorphlogopite, Polysorbate 20, Triethoxycaprylylsilane, Bis-Phenylpropyl Dimethicone, Sodium Starch Octenylsuccinate, Ethylhexylglycerin,
    Ethylbisiminomethylguaiacol Manganese Chloride, Phenoxyethanol. May Contain: Iron Oxides (CI 77491/77492/77499).

  • OTHER INFORMATION

    PROTECT THIS PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

  • PRINCIPAL DISPLAY PANEL

    Bliss_Exglow_SerumFoundation_R2_1 7 pdf FINAL

  • INGREDIENTS AND APPEARANCE
    EX-GLOW-SION  SPF-20
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69863-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.75 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    SILICON (UNII: Z4152N8IUI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALCOHOL (UNII: 3K9958V90M)  
    QUATERNIUM-18 HECTORITE (UNII: IIS3YBV1XX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEACH JUICE (UNII: K37IH01KN1)  
    VITIS VINIFERA WHOLE (UNII: 22E66I250J)  
    OENOTHERA BIENNIS (UNII: 76UI55V071)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    AMARANTHUS CAUDATUS SEED (UNII: FJ722PPQ9M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCROSE PALMITATE (UNII: 3OSQ643ZK5)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PERFLUNAFENE (UNII: 54A06VV62N)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69863-103-511 in 1 BOX
    1NDC:69863-103-1130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:69863-103-127 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/16/2015
    Labeler - HATCHBEAUTY PRODUCTS LLC (044612361)
    Registrant - HATCHBEAUTY PRODUCTS LLC (044612361)

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