Label: BIORLX LIP BALM COLLAGEN- avobenzone, mineral oil, octinoxate, petrolatum, zinc oxide stick

  • NDC Code(s): 80554-002-01, 80554-002-02
  • Packager: LOTUSA LLC.
  • Category: HUMAN OTC DRUG LABEL

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 September 18, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    a. Avobenzone 1.0%w/w

    b. Mineral Oil 30.0%w/w

    c. Octinoxate 6.0% w/w

    d. Petrolatum 30.0% w/w

    e. Zinc Oxide 6.0% w/w

    f. Aloe Barbadensis (Alove Vera) Leaf Juice

    g. Beeswax

    h. Butyrpsoermum (Shea) Parkii Butter

    i.Caprylic/ Capric Triglyceride

    j. Ceresin

    k.Collagen

    l. Microcrystalline Wax

    m. Potassium Sorbate

    n. Tocopherol

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Avobenzone 1.0% w/w Sunscreen
    Mineral Oil 30.0% w/w Skin protectant
    Octinoxate 6.0% w/w Sunscreen
    Petrolatum 30.0% w/w Skin protectant
    Zinc Oxide 6.0% w/w Sunscreen

  • Purpose

    Sunscreen, Skin protectant, Lip Balm

  • Use

    Helps prevent sunburn if use as directed with other sun protection measures.
    provides moderate protection against sunburn
    Helps temporarily protect chapped and cracked lips.

  • Warnings

    For external use only.

  • Do not use

    in children less than 6 months of age on damaged or broken skin if you are allergic to any ingredients

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if rash or irritation develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Apply as needed. Apply liberally 15 minutes before sun exposure. Reapply after 60 minutes of swimming or sweatig, immediately after towel drying at leaft every 2 hours. For best results use daily.

  • Other information

    • Spending time in the sun increases your risk of skin cancer and early aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other longsleeve shirts, pants or hats and sunglassess.
      Store at room temperature
  • Inactive ingredients

    Aloe Barbadensis (Alove Vera) Leaf Juice, Beeswax, Butyrpsoermum (Shea) Parkii Butter, Caprylic/ Capric Triglyceride, Ceresin, Collagen, Microcrystalline Wax, Potassium Sorbate, Tocopherol

  • Package Label - Principal Display Panel

    12x3.5 g NDC:80554-002-01

    collagen

  • INGREDIENTS AND APPEARANCE
    BIORLX LIP BALM COLLAGEN 
    avobenzone, mineral oil, octinoxate, petrolatum, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80554-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    COLLAGEN ALPHA-1(I) CHAIN BOVINE (UNII: FB3DQM32F2)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CERESIN (UNII: Q1LS2UJO3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80554-002-0212 in 1 BOX09/01/2020
    1NDC:80554-002-013.5 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/30/2020
    Labeler - LOTUSA LLC. (122415153)
    Registrant - LOTUSA LLC. (122415153)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRENCH MALIHOME PERSONAL PRODUCTS LIMITED664283791manufacture(80554-002)