Label: ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE CARAMEL- octinoxate, zinc oxide stick

  • 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 June 17, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Octinoxate 7.50% Sunscreen

    Zinc Oxide 4.90% Sunscreen

  • PURPOSE

    Uses

    • Helps prevent sunburn.
  • 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.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • WARNINGS

    Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients: octyldodecanol, ethylhexyl palmitate, polyethylene, ozokerite, silica, jojoba esters, copernicia cerifera (carnauba) wax, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, helianthus annuus (sunflower) seed wax, hexyl laurate, tocopheryl acetate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, schinus terebinthifolia seed extract, phenoxyethanol, tridecyl stearate, dimethicone, acacia decurrens flower wax, polyglycerin-3, triethoxycaprylylsilane, neopentyl glycol dicaprylate/dicaprate, caprylyl glycol, chlorphenesin, trimethylsiloxysilicate, ceramide np, lecithin.
    may contain:
    mica, titanium dioxide, synthetic fluorphlogopite, iron oxides, yellow 5 lake, red 7 lake, red 6 lake, talc.

  • OTHER SAFETY INFORMATION

    Other information

    • Protect the product in this container from excessive heat and direct sun
  • Ultra Balm SPF 20 Nude Caramel

    L'BEL

    ULTRA BALM

    Moisturizing protective balm for lips SPF 20 Nude Caramel

    Net. Wt. 0.14 oz (4 g)

    Nude Caramel

  • INGREDIENTS AND APPEARANCE
    ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE CARAMEL 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-457
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BRAZILIAN PEPPER (UNII: SUG822G7CD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-457-014 g in 1 CARTON; Type 0: Not a Combination Product06/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/16/2021
    Labeler - BEL STAR S A (880160197)
    Establishment
    NameAddressID/FEIBusiness Operations
    BEL STAR S A880160197manufacture(14141-457)
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