SACHET ACTIVE ARGAN 02.3 PLASMA PRO 50 FEATHERWEIGHT DAY BROAD SPECTRUM SPF 20 WITH PROPRIETARY A.P.I. AND ACTIVATED ARGAN COMPLEX (ZINC OXIDE) CREAM [SIBORG]

SACHET ACTIVE ARGAN 02.3 PLASMA PRO 50 FEATHERWEIGHT DAY BROAD SPECTRUM SPF 20 WITH PROPRIETARY A.P.I. AND ACTIVATED ARGAN COMPLEX (ZINC OXIDE) CREAM [SIBORG]
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NDC 70803-500-01
Set ID 432a5c8f-4cdb-0138-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Siborg
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active ingredients

    Zinc oxide 14%

    Purpose

    Sunscreen

  • Uses

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

  • 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.

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

  • Directions

    • apply liberally and evenly 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin 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 • Children under 6 months of age: Ask a doctor

  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    water (aqua) (*oxygen-rich purified water), dicaprylyl carbonate, dimethicone, glycerin, caprylic/capric triglyceride, cetyl PEG/PPG-10/1 dimethicone, phenyl trimethicone, cetyl dimethicone, sodium chloride, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, argania spinosa kernel oil (*specially-ozonized organic argan oil), tocopherol (*GMO-free vegetable vitamin E), wheat (triticum vulgare) germ oil, amyris balsamifera bark oil, tocopheryl acetate, ceramide 1, ceramide 6-II, ceramide 3, phytosphingosine, acacia decurrens/jojoba/sunflower seed wax/polyglyceryl-3 esters, triethoxycaprylylsilane, polyglyceryl-3 diisostearate, isopropyl myristate, BHT, carbomer, xanthan gum, sodium lauroyl lactylate, cholesterol, ethylhexylglycerin, fragrance (*100% natural fragrance), phenoxyethanol

  • Package Labeling

    Label1Label

  • INGREDIENTS AND APPEARANCE
    SACHET ACTIVE ARGAN 02.3 PLASMA PRO 50 FEATHERWEIGHT DAY BROAD SPECTRUM SPF 20 WITH PROPRIETARY A.P.I. AND ACTIVATED ARGAN COMPLEX 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70803-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION140 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70803-500-011 in 1 PACKAGE12/08/2016
    12 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/08/2016
    Labeler - Siborg (102875148)

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