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 
Stila Styles

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.

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jane.® Be Beautiful
Multi-Benefit BB Broad Spectrum SPF 30

Drug Facts

Active IngredientsPurpose
Octinoxate 5.00%Sunscreen
Zinc Oxide 18.60%Sunscreen

Uses

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:

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

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

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
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)

Revised: 1/2014
Document Id: 89d9b005-7f25-436a-a976-38c75dab56b7
Set id: 37154826-c34a-416d-a9a3-5004156dccd6
Version: 1
Effective Time: 20140116
 
Stila Styles