ULTRA SHADE SUNSCREEN SPF 30 TAHERI MD (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LA LASER CENTE, PC, CALIFORNIA PROFESSIONAL MEDICAL CORP]

ULTRA SHADE SUNSCREEN SPF 30 TAHERI MD (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LA LASER CENTE, PC, CALIFORNIA PROFESSIONAL MEDICAL CORP]
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NDC 70919-001-01
Set ID 1d9a237d-5d3a-4ad8-8e58-280a0771bd5f
Category HUMAN OTC DRUG LABEL
Packager LA LASER CENTE, PC, CALIFORNIA PROFESSIONAL MEDICAL CORP
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients                     Purpose

    Titanium Dioxide 5.00%              Sunscreen

    Zinc Oxid 10.00%

  • PURPOSE

    Uses

    • Helps prevent sunburn
  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    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 prevent sunburn, not skin cancer or early skin aging.

    - For external use only. 

    - Do not use on damage or broken skin.

    - Whenn using this product keep out of eyes. Rinse with water to remove

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply generously 15 minutes before sun exposure
    • Reapply:

    -after 80 minutes of swimming or sweating

    -immediatley after towel drying

    - at least every 2 hours

    • Chirldren under 6 months of age: ask a doctor
  • INACTIVE INGREDIENT

    Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Alumina, Aqua, Butylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Cetearyl Alcohol,

    Coco-Caprylate/Caprate, Coconut Alkanes, Cyclopentasiloxane, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Iron Oxides, Laureth-7, Octoyldodecyl Neopentanoate, Polyhydroxystearic Acid, Triethanolamine, Xanthan Gum 

  • PRINCIPAL DISPLAY PANEL

    TAHERI MD

    Ultra Shade Sunscreen SPF 30

    Non- Comedogenic

    1.7 0z / 50 ml

    Sunscreen Label

  • INGREDIENTS AND APPEARANCE
    ULTRA SHADE SUNSCREEN SPF 30  TAHERI MD
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70919-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LAURETH-7 (UNII: Z95S6G8201)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70919-001-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/17/2016
    Labeler - LA LASER CENTE, PC, CALIFORNIA PROFESSIONAL MEDICAL CORP (080323225)
    Registrant - LA LASER CENTE, PC, CALIFORNIA PROFESSIONAL MEDICAL CORP (080323225)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEGE-KURL, INC021072509manufacture(70919-001)

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