A PERFECT WORLD SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA (OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [ORIGINS NATURAL RESOURCES INC]

A PERFECT WORLD SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA (OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [ORIGINS NATURAL RESOURCES INC]
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NDC 59427-702-01, 59427-702-02
Set ID cb71bd18-6fa9-4ba1-8c11-22fa6764a2d8
Category HUMAN OTC DRUG LABEL
Packager ORIGINS NATURAL RESOURCES INC
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    avobenzone 3.00%Sunscreen
    octisalate 5.00%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; citrus aurantium amara (bitter orange) flower water, anthemis nobilis (chamomile) flower water ∙ butyloctyl salicylate ∙ ethyl macadamiate ∙ methyl trimethicone jojoba esters ∙ butylene glycol ∙ lauryl peg-9 polydimethylsiloxyethyl dimethicone ∙ peg-100 stearate ∙ glyceryl stearate ∙ citrus aurantium bergamia (bergamot) fruit oil1, citrus medica limonum (lemon) peel oil1, citrus aurantium dulcis (orange) oil1, cinnamomum camphora (camphor) bark oil1, mentha viridis (spearmint) leaf oil1, magnolia acuminata flower extract, iris pallida (orris) root extract, rosa damascena (rose) extract, citral, linalool, limonene ∙ camellia sinensis (white tea) leaf extract ∙ pinus pinaster bark/bud extract ∙ arabidopsis thaliana extract ∙ ascorbyl tocopheryl maleate ∙ oryzanol ∙ ergothioneine ∙ triticum vulgare (wheat) germ extract ∙ hordeum vulgare (barley) extract ∙ cholesterol ∙ caffeine ∙ mangifera indica (mango) seed butter ∙ butyrospermum parkii (shea butter) ∙ potassium cetyl phosphate ∙ cetyl alcohol ∙ ethylhexylglycerin ∙ linoleic acid ∙ squalane ∙ sodium hyaluronate ∙ caprylyl glycol ∙ dehydroxanthan gum ∙ silica ∙ ammonium acryloyldimethyltaurate/vp copolymer ∙ citric acid ∙ sodium stearate ∙ sodium dehydroacetate ∙ phenoxyethanol ∙ mica <iln36381>


    1
    essential oil
  • Other information

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

  • SPL UNCLASSIFIED SECTION

    ©Origins Nat. Res., Dist. NY, NY 10022

  • PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

    ORIGINS

    A Perfect WorldSPF 25
    Age-defense moisturizer with White Tea

    Broad Spectrum SPF 25

    net wt. 1.7 oz./50 ml e

    PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    A PERFECT WORLD  SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA
    octisalate, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-702
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)  
    CHAMOMILE (UNII: FGL3685T2X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    MAGNOLIA ACUMINATA FLOWER (UNII: 8LCB7ZW9UL)  
    IRIS PALLIDA ROOT (UNII: LVV57EM5OG)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    WHEAT GERM (UNII: YR3G369F5A)  
    BARLEY (UNII: 5PWM7YLI7R)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CAFFEINE (UNII: 3G6A5W338E)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    SQUALANE (UNII: GW89575KF9)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59427-702-011 in 1 CARTON
    1NDC:59427-702-0250 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/01/2010
    Labeler - ORIGINS NATURAL RESOURCES INC (611716283)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC Kabushiki Kaisha712808195RELABEL(59427-702) , REPACK(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59427-702) , RELABEL(59427-702) , REPACK(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    ARAMIS, INC042918826MANUFACTURE(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59427-702) , RELABEL(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE787336577MANUFACTURE(59427-702) , RELABEL(59427-702) , REPACK(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL949264774MANUFACTURE(59427-702) , REPACK(59427-702) , RELABEL(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE618107429MANUFACTURE(59427-702) , REPACK(59427-702) , RELABEL(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59427-702)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(59427-702)

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