Label: VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene cream

  • NDC Code(s): 59427-013-01
  • Packager: ORIGINS NATURAL RESOURCES INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 5, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    avobenzone 3.00%Sunscreen
    octisalate 3.00%Sunscreen
    octocrylene 2.70%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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    • apply generously and evenly 15 minutes before sun exposure
    • reapply at least every two 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 10am – 2pm
      • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
  • Inactive ingredients

    water\aqua\eau • ethyl macadamiate • butylene glycol • methyl trimethicone • hdi/trimethylol hexyllactone crosspolymer • lauryl peg-9 polydimethylsiloxyethyl dimethicone • peg-100 stearate • butyloctyl salicylate • jojoba esters • glyceryl stearate • barosma betulina leaf oil 1, citrus paradisi (grapefruit) peel oil 1, eucalyptus globulus (eucalyptus) leaf oil 1, abies sibirica (pine) oil 1, prunus amygdalus amara (bitter almond) kernel oil 1, mentha arvensis (field mint) leaf oil 1, rosa damascena (rose) oil 1, limonene • panax ginseng (ginseng) root extract • cordyceps sinensis extract • garcinia mangostana peel extract • castanea sativa (chestnut) seed extract • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • laminaria saccharina extract • mangifera indica (mango) seed butter • butyrospermum parkii (shea butter) • caffeine • citrus aurantium amara (bitter orange) flower water • anthemis nobilis (chamomile) flower extract • potassium cetyl phosphate • glycerin • cetyl alcohol • isopropyl myristate • trehalose • ethylhexylglycerin • linoleic acid • squalane • polymethyl methacrylate • dehydroxanthan gum • ascorbyl tocopheryl maleate • glyceryl acrylate/acrylic acid copolymer • sodium hyaluronate • caprylyl glycol • ammonium acryloyldimethyltaurate/vp copolymer • citric acid • stearic acid • silica • sodium dehydroacetate • phenoxyethanol • mica • iron oxides (ci 77491, ci 77492, ci 77499) • titanium dioxide (ci 77891) <iln44030>

    1
    essential oil
  • Other information

    protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

    ORIGINS

    VITAZING™
    SPF 15

    Energy-Boosting
    Moisturizer
    with Mangosteen
    Broad Spectrum
    SPF 15

    Sheer Tint Release

    1.7 fl. oz./oz. liq./50 ml e

    PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15 
    avobenzone, octisalate, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WHITE PINE OIL (UNII: HA5CX6676U)  
    BITTER ALMOND OIL (UNII: 6TQK77W0EX)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    ROSE OIL (UNII: WUB68Y35M7)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    BARLEY (UNII: 5PWM7YLI7R)  
    WHEAT (UNII: 4J2I0SN84Y)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAFFEINE (UNII: 3G6A5W338E)  
    BITTER ORANGE (UNII: DQD16J2B5O)  
    CHAMOMILE (UNII: FGL3685T2X)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    SQUALANE (UNII: GW89575KF9)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59427-013-011 in 1 CARTON01/01/2017
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/01/2017
    Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(59427-013) , pack(59427-013) , label(59427-013)
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