Label: JANE BE BEAUTIFUL MULTI-BENEFIT BB BROAD SPECTRUM SPF 30 LIGHT- octinoxate and zinc oxide cream
JANE BE BEAUTIFUL MULTI-BENEFIT BB BROAD SPECTRUM SPF 30 MEDIUM- octinoxate and zinc oxide cream
JANE BE BEAUTIFUL MULTI-BENEFIT BB BROAD SPECTRUM SPF 30 DARK- octinoxate and zinc oxide cream

  • 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 January 16, 2014

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 5.00%Sunscreen
    Zinc Oxide 18.60%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 ask a doctor if rash occurs.

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

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use water resistant sunscreen if swimming or sweating

    Sun Protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 am - 2 pm
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: ask a doctor
  • Other Information

    • protect the product in this container from excessive heat and direct sun
  • Inactive Ingredients

    Butylphenyl Methyl Propional, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cyclopentasiloxane, Decarboxy Carnosine HCl, Dimethicone, Dimethicone Crosspolymer, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hexyl Cinnamic Aldehyde, Hexylene Glycol, Hydroxypropylcocoate PEG-8 Dimethicone, Isododecane, Isopentyldiol, Limonene, Linalool, Palmitoyl Tripeptide-37, PEG/PPG-18/18 Dimethicone, Phenoxyethanol, Physalis Angulata Extract, Phytic Acid, Polyhydroxystearic Acid, Propylene Carbonate, Pyrus Malus (Apple) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Sodium Chloride, Sodium Hydroxide, Tin Oxide, Tocopherol, Triethoxycaprylylsilane, Water (Aqua), May Contain (+/-): Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) <ILNJ121030>.

  • Questions?

    janecosmetics.com

  • SPL UNCLASSIFIED SECTION

    Dist. by Jewel of Jane, LLC Glendale, CA
    91209 • Biorius Sprl  2 Rue René
    Descartes b-7000 Mons, Belgium

  • PRINCIPAL DISPLAY PANEL - 30 ml Tube - Light

    Light

    jane.®

    Be Beautiful
    Multi-Benefit BB Cream
    BROAD SPECTRUM SPF 30

    Water-Resistant (80 minutes)
    1 FL. OZ./30 ml

    Principal Display Panel - 30 ml Tube - Light
  • PRINCIPAL DISPLAY PANEL - 30 ml Tube - Medium

    Medium

    jane.®

    Be Beautiful
    Multi-Benefit BB Cream
    BROAD SPECTRUM SPF 30

    Water-Resistant (80 minutes)
    1 FL. OZ./30 ml

    Principal Display Panel - 30 ml Tube - Medium
  • PRINCIPAL DISPLAY PANEL - 30 ml Tube - Dark

    Dark

    jane.®

    Be Beautiful
    Multi-Benefit BB Cream
    BROAD SPECTRUM SPF 30

    Water-Resistant (80 minutes)
    1 FL. OZ./30 ml

    Principal Display Panel - 30 ml Tube - Dark
  • INGREDIENTS AND APPEARANCE
    JANE BE BEAUTIFUL   MULTI-BENEFIT BB BROAD SPECTRUM SPF 30 LIGHT
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76049-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE186 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Butylphenyl Methylpropional (UNII: T7540GJV69)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Decarboxy Carnosine Hydrochloride (UNII: 6X7K9I5QR7)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    .Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Hydroxypropylcocoate Peg-8 Dimethicone (UNII: 8TE0BZU36S)  
    Isododecane (UNII: A8289P68Y2)  
    Isopentyldiol (UNII: 19NOL5474Q)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Physalis Angulata (UNII: W4TKW9D5GG)  
    Fytic Acid (UNII: 7IGF0S7R8I)  
    Propylene Carbonate (UNII: 8D08K3S51E)  
    Apple (UNII: B423VGH5S9)  
    Rosemary (UNII: IJ67X351P9)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Tocopherol (UNII: R0ZB2556P8)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Water (UNII: 059QF0KO0R)  
    Mica (UNII: V8A1AW0880)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76049-123-0130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35210/31/2013
    JANE BE BEAUTIFUL   MULTI-BENEFIT BB BROAD SPECTRUM SPF 30 MEDIUM
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76049-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE186 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Butylphenyl Methylpropional (UNII: T7540GJV69)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Decarboxy Carnosine Hydrochloride (UNII: 6X7K9I5QR7)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    .Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Hydroxypropylcocoate Peg-8 Dimethicone (UNII: 8TE0BZU36S)  
    Isododecane (UNII: A8289P68Y2)  
    Isopentyldiol (UNII: 19NOL5474Q)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Physalis Angulata (UNII: W4TKW9D5GG)  
    Fytic Acid (UNII: 7IGF0S7R8I)  
    Propylene Carbonate (UNII: 8D08K3S51E)  
    Apple (UNII: B423VGH5S9)  
    Rosemary (UNII: IJ67X351P9)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Stannic Oxide (UNII: KM7N50LOS6)  
    Tocopherol (UNII: R0ZB2556P8)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Water (UNII: 059QF0KO0R)  
    Mica (UNII: V8A1AW0880)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76049-122-0130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35210/31/2013
    JANE BE BEAUTIFUL   MULTI-BENEFIT BB BROAD SPECTRUM SPF 30 DARK
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76049-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE186 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Butylphenyl Methylpropional (UNII: T7540GJV69)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Decarboxy Carnosine Hydrochloride (UNII: 6X7K9I5QR7)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    .Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Hydroxypropylcocoate Peg-8 Dimethicone (UNII: 8TE0BZU36S)  
    Isododecane (UNII: A8289P68Y2)  
    Isopentyldiol (UNII: 19NOL5474Q)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Physalis Angulata (UNII: W4TKW9D5GG)  
    Fytic Acid (UNII: 7IGF0S7R8I)  
    Propylene Carbonate (UNII: 8D08K3S51E)  
    Apple (UNII: B423VGH5S9)  
    Rosemary (UNII: IJ67X351P9)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Tocopherol (UNII: R0ZB2556P8)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Water (UNII: 059QF0KO0R)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76049-121-0130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35210/31/2013
    Labeler - Stila Styles (809192896)
    Establishment
    NameAddressID/FEIBusiness Operations
    GORDON LABORATORIES, INC.008328619MANUFACTURE(76049-123, 76049-122, 76049-121)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!