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

  • 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 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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