Label: LBEL PARIS- octinoxate, octocrylene, and oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated August 10, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate (7.5 %), Octocrylene (5 %), Oxybenzone (3 %)

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Provides moderate protection against sunburn
  • Warnings

    • For external use only.

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash and irritation develops and lasts.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply smoothly every morning before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
  • Other information

    • Moderate sun protection product.
    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    Aqua (water), cyclohexasiloxane, soy protein phthalate, glycerin, pisum sativum (pea) extract, c12-15 alkyl benzoate, caprylic / capric triglyceride, cyclopentasiloxane, cetyl alcohol, cetearyl alcohol, isopropyl myristate, isononyl isononanoate, sorbitan stearate, mannitol, glyceryl stearate, potassium cetyl phosphate, dimethicone / vinyl dimethicone crosspolymer, dimethicone crosspolymer, triethanolamine, acrylates / c10-30 alkyl acrylate crosspolymer, ceteareth-20, propylparaben, panthenol, sodium pca, steareth-20, ceteth-20, parfum (fragance), ci 77891 (titanium dioxide), chlorphenesin, dimethiconol, teprenone, ppg-26-buteth-26, polysorbate 80, peg-40 hydrogenated castor oil, tetrasodium edta, cyclodextrin, butylene glycol, hydrolyzed algin, hedera helix (ivy) leaf / stem extract, faex extract (yeast extract), magnesium pca, chlorella vulgaris extract, maris aqua (sea water), algin, tocopheryl acetate, zinc pca, retinyl palmitate, saccharomyces / magnesium ferment, ascorbyl palmitate, serine, urea, acacia, senegal gum, bioflavonoids, allantoin, disodium succinate, saccharomyces /iron ferment, manganese pca, saccharomyces /copper ferment, saccharomyces /calcium ferment, saccharomyces /silicon ferment, saccharomyces /zinc ferment.

  • SPL UNCLASSIFIED SECTION

    US: Distributed by Ventura International Ltd. San Francisco, CA 94111

  • PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

    L'BEL

    RENOVÂNCE JOUR

    intensive refining, fortifying and renewing treatment
    spf 15 daytime face and neck cream

    50 g e (1.7 oz.)

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    LBEL PARIS   RENOVANCE JOUR
    octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.75 g  in 50 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.5 g  in 50 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    glycerin (UNII: PDC6A3C0OX)  
    snow pea (UNII: 84SKC33B1I)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cetyl alcohol (UNII: 936JST6JCN)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    isononyl isononanoate (UNII: S4V5BS6GCX)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    mannitol (UNII: 3OWL53L36A)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    trolamine (UNII: 9O3K93S3TK)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    panthenol (UNII: WV9CM0O67Z)  
    sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
    steareth-20 (UNII: L0Q8IK9E08)  
    ceteth-20 (UNII: I835H2IHHX)  
    chlorphenesin (UNII: I670DAL4SZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    teprenone (UNII: S8S8451A4O)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    edetate sodium (UNII: MP1J8420LU)  
    butylene glycol (UNII: 3XUS85K0RA)  
    kalmia latifolia leaf (UNII: 79N6542N18)  
    yeast (UNII: 3NY3SM6B8U)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    serine (UNII: 452VLY9402)  
    urea (UNII: 8W8T17847W)  
    acacia (UNII: 5C5403N26O)  
    allantoin (UNII: 344S277G0Z)  
    sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-038-611 in 1 BOX
    1NDC:14783-038-6250 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/15/2010
    LBEL PARIS   RENOVANCE JOUR
    octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.375 g  in 5 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.25 g  in 5 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.15 g  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    glycerin (UNII: PDC6A3C0OX)  
    snow pea (UNII: 84SKC33B1I)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cetyl alcohol (UNII: 936JST6JCN)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    isononyl isononanoate (UNII: S4V5BS6GCX)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    mannitol (UNII: 3OWL53L36A)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    trolamine (UNII: 9O3K93S3TK)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    panthenol (UNII: WV9CM0O67Z)  
    sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
    steareth-20 (UNII: L0Q8IK9E08)  
    ceteth-20 (UNII: I835H2IHHX)  
    chlorphenesin (UNII: I670DAL4SZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    teprenone (UNII: S8S8451A4O)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    edetate sodium (UNII: MP1J8420LU)  
    butylene glycol (UNII: 3XUS85K0RA)  
    kalmia latifolia leaf (UNII: 79N6542N18)  
    yeast (UNII: 3NY3SM6B8U)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    serine (UNII: 452VLY9402)  
    urea (UNII: 8W8T17847W)  
    acacia (UNII: 5C5403N26O)  
    allantoin (UNII: 344S277G0Z)  
    sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-028-511 in 1 BOX
    1NDC:14783-028-525 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/15/2010
    LBEL PARIS   RENOVANCE JOUR
    octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.05 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    glycerin (UNII: PDC6A3C0OX)  
    snow pea (UNII: 84SKC33B1I)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cetyl alcohol (UNII: 936JST6JCN)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    isononyl isononanoate (UNII: S4V5BS6GCX)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    mannitol (UNII: 3OWL53L36A)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    trolamine (UNII: 9O3K93S3TK)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    propylparaben (UNII: Z8IX2SC1OH)  
    panthenol (UNII: WV9CM0O67Z)  
    sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
    steareth-20 (UNII: L0Q8IK9E08)  
    ceteth-20 (UNII: I835H2IHHX)  
    chlorphenesin (UNII: I670DAL4SZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    teprenone (UNII: S8S8451A4O)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    edetate sodium (UNII: MP1J8420LU)  
    butylene glycol (UNII: 3XUS85K0RA)  
    kalmia latifolia leaf (UNII: 79N6542N18)  
    yeast (UNII: 3NY3SM6B8U)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    serine (UNII: 452VLY9402)  
    urea (UNII: 8W8T17847W)  
    acacia (UNII: 5C5403N26O)  
    allantoin (UNII: 344S277G0Z)  
    sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-018-411 in 1 BOX
    1NDC:14783-018-421 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/15/2010
    Labeler - Ventura International LTD (603192787)
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