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

jane Be Beautiful by

Drug Labeling and Warnings

jane Be Beautiful by is a Otc medication manufactured, distributed, or labeled by Stila Styles, GORDON LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
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 - 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 - Dark

Dark

jane.®

Be Beautiful
Multi-Benefit BB Cream
BROAD SPECTRUM SPF 30

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76049-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	186 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76049-123-01	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/31/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76049-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	186 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76049-122-01	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/31/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76049-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	186 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76049-121-01	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/31/2013

Labeler - Stila Styles (809192896)

Establishment
Name	Address	ID/FEI	Business Operations
GORDON LABORATORIES, INC.		008328619	MANUFACTURE(76049-123, 76049-122, 76049-121)