Label: LE LOU COLLAGEN DAY SPF 30- octinoxate, octisalate, zinc oxide cream

  • NDC Code(s): 70833-758-01
  • Packager: Dougoud Cosmetics, LLC
  • 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 February 10, 2017

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

  • Drug Facts

  • ACTIVE INGREDIENTS

    Octinoxate  7.50%

    Octisalate  3.00%

    Zinc Oxide  3.00%

    PURPOSE

    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 borken skin.

    When using this product

    keep out of eyes.  Rinse with water to remove.

    Stop use and consult physician

    if irritation or rash develops.

    Keep out of reach of children.

    If product is swalloed, get medical help or contact poison control center immediately.

  • DIRECTIONS:

    Apply liberally 15-minutes before sun exposure.  Reapply:  * At least every two-hours.  * Immediately after swimming, sweating or towel drying.

    ​SUN PROTECTION MEASURES: ​Spending time in the sun increases your risk of skin cancer and early sun again.  To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

    • Limit time in the sun, especially between 10 am and 2 pm.
    • Wear long sleeve shirts, pants, hats and sunglasses.
    • For children under 6-months, consult a physician.
  • ​OTHER INGREDIENTS:

    Aloe barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Butyropermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cetearyl Olivate, Cocamidopropyl Betaine, Cucumis Sativus (Cucumber) extract, Cyclopentasiloxane, Cyclotetrasiloxane, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Glyceryl Sterate, PEG-100 Stearate, C13-14 Isoparaffin, Hydrolyzed Collagen, Isopropyl Myristate, Laureth-7, Magnifera Indica (Mango) Butter, Parfum (Fragrance), Phenoxyethanol, Polyacrylamide, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

  • OTHER INFORMATION:

    Protect this product from excessive heat and direct sunlight.

  • Questions or Comments?

    Distributed by Dougoud Cosmetics, LLC, sales@dougoud.com, Miami, FL USA

  • PACKAGE LABELING:

    Label

  • INGREDIENTS AND APPEARANCE
    LE LOU COLLAGEN DAY SPF 30 
    octinoxate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70833-758
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70833-758-01113.4 g in 1 JAR; Type 0: Not a Combination Product08/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/16/2016
    Labeler - Dougoud Cosmetics, LLC (006843180)