SUNSCREEN SPF 30 (ZINC OXIDE) CREAM [HAMILTON THERAPEUTICS]

SUNSCREEN SPF 30 (ZINC OXIDE) CREAM [HAMILTON THERAPEUTICS]
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NDC 72381-102-01
Set ID 6e65bbab-954a-30ee-e053-2a91aa0a18ac
Category HUMAN OTC DRUG LABEL
Packager Hamilton Therapeutics
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredient Purpose
    Zinc Oxide 15% .......................................................... Sunscreen

  • PURPOSE

    Uses

    • Helps prevent sunburn

    • If used as directed with other sun protection measures ( see Directions), decreases the risk of
    skin cancer and early aging caused by the sun.

  • 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.

  • INDICATIONS & USAGE

    • Stop use and ask a doctor if rash occurs.

  • WARNINGS

    Warnings

    For external use only

    When using this product keep out of eyes.

    • Rinse with water to remove.

    • Do not use on damaged or broken skin.

  • DOSAGE & ADMINISTRATION

    Directions

    • For full protection, apply liberally 15 minutes before sun exposure.

    • Reapply: • After 40 minutes of swimming or sweating • immediately after towel drying

    • at least every 2 hours.

    • For children under 6 months: Ask a doctor. • Sun Protection Measures: To decrease risk of exposure, regularly use a Broad Spectrum Sunscreen with an SPF of 15 or higher.

    • Limit time in the sun, especially from 10AM-2PM.

    • Wear long-sleeved shirts, pants, hats and sunglasses.

  • INACTIVE INGREDIENT

    Inactive ingredients Water, Caprylyl Caprylate/Caprate, Coconut Alkanes, Potassium Cetyl Phosphate, Cetearyl Alcohol, Glycerin, Bisabolol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Coco-Caprylate/Caprate, Glyceryl Stearate, Xanthan Gum, Polyhydroxystearic Acid, Glyceryl Distearate, Stearic Acid, Potassium Stearate, Octyldodecanol, Ethylhexyl Neopentanoate, Dimethicone, Phenethyl Alcohol, Sodium Dehydroacetate, Caprylhydroxamic Acid.

  • PRINCIPAL DISPLAY PANEL

    SPF 30 Sunscreen

    3.3FL OZ / 98mL

    tube

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72381-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    LEMON PEEL (UNII: 72O054U628)  
    SAGE (UNII: 065C5D077J)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POTASSIUM STEARATE (UNII: 17V812XK50)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    THYME (UNII: CW657OBU4N)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72381-102-0198 mL in 1 TUBE; Type 0: Not a Combination Product06/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/15/2018
    Labeler - Hamilton Therapeutics (099419360)

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