Label: LBRI PURE NNATURAL OIL FREE MOISTURIZER- octinoxate, avobenzone, octisalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • DRUG FACTS:

  • Active Ingredients:

    Octinoxate 7.50%

    Avobenzone 3.00%

    Octisalate 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 broken 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 swallowed, get medical attention or contact poison control center immediately.

  • DIRECTIONS:

    • Apply liberally 15-minutes before sun exposure.
    • Reapply:
    • Limit time in the sun, especially between 10am and 2pm.
    • Wear long sleeve shirts, pants, hats and sunglasses.
    • For children under 6-months, consult a physician.

       -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 skin aging. 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:

  • OTHER INGREDIENTS:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bee Pollen Extract, C12-15 Alkyls Benzoate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Dimethicone, Disodium EDTA, Equisetum Arvense (Horsetail) Extract, Ethylhexylglycerin, Glyceryl Stearate, Hypericum Perforatum (St. John's Wort) Extract, Melissa Officinalis (Mint Balm) Extract, PEG-100 Stearate, Phenoxyethanol, Pinus Pinaster (Pine) Needle Extract, Pinus Strobus (Pine) Bark Extract, Polysorbate-20, Stearic Acid, Symphytum Officinale (Comfrey) Extract, Triethanolamine.

  • Other Information:

    • Protect this product from excessive heat and direct sunlight.
  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    LBRI PURE NNATURAL OIL FREE MOISTURIZER 
    octinoxate, avobenzone, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71238-785
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    MELISSA OFFICINALIS (UNII: YF70189L0N)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PINUS STROBUS BARK (UNII: 8PJ4761097)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71238-785-18118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/07/2017
    Labeler - L'Bri Health & Beauty (139751148)
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