Label: A PERFECT WORLD SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA- octisalate, avobenzone and octocrylene lotion

  • NDC Code(s): 59427-702-01, 59427-702-02
  • Packager: ORIGINS NATURAL RESOURCES INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    avobenzone 3.00% Sunscreen
    octisalate 5.00% Sunscreen
    octocrylene 2.70% Sunscreen
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  • 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
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  • 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.

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  • 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
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  • 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
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  • Other information

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

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  • SPL UNCLASSIFIED SECTION

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    A PERFECT WORLD  SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA
    octisalate, avobenzone, octocrylene lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59427-702
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTISALATE (OCTISALATE) OCTISALATE 5 mL  in 100 mL
    AVOBENZONE (AVOBENZONE) AVOBENZONE 3 mL  in 100 mL
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 2.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CITRUS AURANTIUM FRUIT  
    CHAMOMILE  
    BUTYLOCTYL SALICYLATE  
    ETHYL MACADAMIATE  
    METHYL TRIMETHICONE  
    BUTYLENE GLYCOL  
    PEG-100 STEARATE  
    GLYCERYL MONOSTEARATE  
    BERGAMOT OIL  
    LEMON OIL  
    ORANGE OIL  
    CAMPHOR OIL  
    SPEARMINT OIL  
    MAGNOLIA ACUMINATA FLOWER  
    IRIS PALLIDA ROOT  
    ROSA DAMASCENA FLOWER  
    CITRAL  
    LINALOOL, (+/-)-  
    MARITIME PINE  
    GAMMA ORYZANOL  
    ERGOTHIONEINE  
    WHEAT GERM  
    BARLEY  
    CHOLESTEROL  
    CAFFEINE  
    MANGIFERA INDICA SEED BUTTER  
    SHEA BUTTER  
    POTASSIUM CETYL PHOSPHATE  
    CETYL ALCOHOL  
    ETHYLHEXYLGLYCERIN  
    LINOLEIC ACID  
    SQUALANE  
    HYALURONATE SODIUM  
    CAPRYLYL GLYCOL  
    SILICON DIOXIDE  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER  
    CITRIC ACID MONOHYDRATE  
    SODIUM STEARATE  
    SODIUM DEHYDROACETATE  
    PHENOXYETHANOL  
    MICA  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59427-702-01 1 in 1 CARTON
    1 NDC:59427-702-02 50 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 12/01/2010
    Labeler - ORIGINS NATURAL RESOURCES INC (611716283)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC Kabushiki Kaisha 712808195 RELABEL(59427-702), REPACK(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(59427-702), RELABEL(59427-702), REPACK(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    ARAMIS, INC 042918826 MANUFACTURE(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(59427-702), RELABEL(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 787336577 MANUFACTURE(59427-702), RELABEL(59427-702), REPACK(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 949264774 MANUFACTURE(59427-702), REPACK(59427-702), RELABEL(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 618107429 MANUFACTURE(59427-702), REPACK(59427-702), RELABEL(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59427-702)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(59427-702)
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