Label: BLACK RICE PLATINUM ABSOLUTE YOUTH SPF 15- avobenzone, ensulizole, octinoxate, and octocrylene cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 23, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Avobenzone 3.0% Sunscreen
    Ensulizole 2.0% Sunscreen
    Octinoxate 2.0 % Sunscreen
    Octocrylene 5.0% 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

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with 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.
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  • Other information

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

    WATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, C12-15 ALKYL BENZOATE, CETEARYL OLIVATE, PENTAERYTHRITYL DISTEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, DIMETHICONE, PVP/HEXADECENE COPOLYMER, ORYZA SATIVA (RICE) BRAN EXTRACT, HYDROLYZED RICE PROTEIN, PANTHENOL, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, EUTERPA OLERACEA FRUIT EXTRACT, XANTHAN GUM, CARBOMER, ETHYLHEXYL PALMITATE, SILICA DIMETHYL SILYLATE, BUTYLENE GLYCOL, SODIUM HYALURONATE, DIAZOLIDINYL UREA, SODIUM HYDROXIDE, FRAGRANCE, BHT, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, CITRONELLOL, BUTYLPHENYL METHYLPROPIONAL, LINALOOL, HEXYL CINNAMAL, LIMONENE, ALPHA-ISOMETHYL IONONE, EUGENOL.

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  • SPL UNCLASSIFIED SECTION

    Distributed in USA Distr.EBPD LLC
    300 Kennedy Drive, Sayreville N.J 08872

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  • PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

    BLACK RICE PLATINUM
    100% ITALIAN RICE EXTRACTS
    BLACK VENERE RICE

    HAND CREAM ABSOLUTE YOUTH
    Global Age-Defying Beauty Solutions

    Sun Screen
    Broad Spectrum
    SPF 15

    PERLIER

    3.3 FL OZ (100mL)

    Principal Display Panel - 100 mL Tube Label
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  • INGREDIENTS AND APPEARANCE
    BLACK RICE PLATINUM ABSOLUTE YOUTH SPF 15 
    avobenzone, ensulizole, octinoxate, and octocrylene cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59582-015
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg  in 1 mL
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole 20 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 20 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Tricaprylin (UNII: 6P92858988)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    Pentaerythritol (UNII: SU420W1S6N)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Sheanut Oil (UNII: O88E196QRF)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Hexadecyl Povidone (4 Hexadecyl Branches/Repeat) (UNII: AG75W62QYU)  
    Rice Bran (UNII: R60QEP13IC)  
    Panthenol (UNII: WV9CM0O67Z)  
    Olea Europaea Leaf (UNII: MJ95C3OH47)  
    Acai (UNII: 46AM2VJ0AW)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Silica Dimethyl Silylate (UNII: EU2PSP0G0W)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59582-015-01 1 in 1 CARTON
    1 100 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 08/15/2013
    Labeler - EBPD LLC (077477227)
    Establishment
    Name Address ID/FEI Business Operations
    ORLANE S.A. 578687469 MANUFACTURE(59582-015)
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