STILA ILLUMINATE AND SHINE- octinoxate, avobenzoate, and octisalate kit

stila illuminate and shine by

Drug Labeling and Warnings

stila illuminate and shine by is a Otc medication manufactured, distributed, or labeled by Stila Styles, LLC, GORDON LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

illuminating tinted moisturizer - shade 01

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 7.5 %	sunscreen
Avobenzone 3%	sunscreen
Octisalate 2%	sunscreen

Uses

Provides moderate protection against sunburn

Warnings

For external use only.

The sun may cause sunburn, premature aging of the skin, and skin cancer. Avoiding the sun, wearing protective clothing, and regular use of sunscreens over the years may reduce the chance of harmful effects.

When using this product

• Keep out of eyes.

Stop use and ask a doctor if

Irritation occurs.

Keep out of reach of children

Directions

Apply to clean skin with fingerstips.

Inactive Ingredients

water (aqua), diethylhexyl carbonate, cyclopentasiloxane, ethylhexyl stearate, diisostearoyl polyglyceryl-3 dimer dilinoleate, glycerin, prunus amygdalus dulcis (sweet almond) oil, alumina, magnesium sulfate, microcrystalline wax/cera microcristallina, cetyl dimethicone, cyclohexasiloxane, hydrogenated castor oil, phenoxyethanol, chlorphenesin, cetyl peg/ppg10/1 dimethicone, polyglyceryl-4 isostearate, hexyl laurate, benzoic acid, butylene glycol, sorbic acid, isopropyl titanium triisostearate, tin oxide may contain (+/-) mica, titanium dioxide (ci77981), iron oxides (ci77491, ci77492, ci77499) <iln c71055>

SPL UNCLASSIFIED SECTION

dist. by © stila styles, llc los angeles, ca 90027

PRINCIPAL DISPLAY PANEL - Kit Label

stila
illuminate and shine

this exclusive set contains stila's best-selling illuminating tinted moisturizer in shade 01,
one step primecolor in kitten and illuminating finishing powder in gold

stilacosmetics.com

INGREDIENTS AND APPEARANCE

STILA ILLUMINATE AND SHINE 
octinoxate, avobenzoate, and octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76049-620

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76049-620-01	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	50 mL
Part 2	1 TUBE	10 mL
Part 3	1 CONTAINER	9 g

Part 1 of 3

ILLUMINATED TINTED MOISTURIZER   SHADE 01
octinoxate, avobenzone, and octisalate lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
diethylhexyl carbonate (UNII: YCD50O0Z6L)
cyclomethicone 5 (UNII: 0THT5PCI0R)
ethylhexyl stearate (UNII: EG3PA2K3K5)
diisostearoyl polyglyceryl-3 dimer dilinoleate (UNII: G3232Z5S2O)
glycerin (UNII: PDC6A3C0OX)
almond oil (UNII: 66YXD4DKO9)
aluminum oxide (UNII: LMI26O6933)
magnesium sulfate (UNII: DE08037SAB)
microcrystalline wax (UNII: XOF597Q3KY)
cyclomethicone 6 (UNII: XHK3U310BA)
hydrogenated castor oil (UNII: ZF94AP8MEY)
phenoxyethanol (UNII: HIE492ZZ3T)
chlorphenesin (UNII: I670DAL4SZ)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
hexyl laurate (UNII: 4CG9F9W01Q)
benzoic acid (UNII: 8SKN0B0MIM)
butylene glycol (UNII: 3XUS85K0RA)
sorbic acid (UNII: X045WJ989B)
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)
stannic oxide (UNII: KM7N50LOS6)
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		1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/31/2013

Part 2 of 3

ONE STEP PRIMECOLOR   KITTEN
foundations lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	dimethicone (UNII: 92RU3N3Y1O)
INGR	water (UNII: 059QF0KO0R)
INGR	isododecane (UNII: A8289P68Y2)
INGR	hydrogenated didecene (UNII: 048B98MT5O)
INGR	silicon dioxide (UNII: ETJ7Z6XBU4)
INGR	silica dimethyl silylate (UNII: EU2PSP0G0W)
INGR	glycerin (UNII: PDC6A3C0OX)
INGR	disteardimonium hectorite (UNII: X687XDK09L)
INGR	tribehenin (UNII: 8OC9U7TQZ0)
INGR	phenoxyethanol (UNII: HIE492ZZ3T)
INGR	tropolone (UNII: 7L6DL16P1T)
INGR	talc (UNII: 7SEV7J4R1U)
INGR	sodium dehydroacetate (UNII: 8W46YN971G)
INGR	edetate disodium (UNII: 7FLD91C86K)
INGR	triethoxycaprylylsilane (UNII: LDC331P08E)
INGR	kaolin (UNII: 24H4NWX5CO)
INGR	montmorillonite (UNII: A585MN1H2L)
INGR	mica (UNII: V8A1AW0880)
INGR	titanium dioxide (UNII: 15FIX9V2JP)
INGR	ferric oxide red (UNII: 1K09F3G675)
INGR	ferric oxide yellow (UNII: EX438O2MRT)
INGR	ferrosoferric oxide (UNII: XM0M87F357)
INGR	carminic acid (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC

Part 3 of 3

ILLUMINATING FINISHING POWDER   GOLD
face powders powder

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	talc (UNII: 7SEV7J4R1U)
INGR	octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)
INGR	.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
INGR	vitamin a palmitate (UNII: 1D1K0N0VVC)
INGR	jojoba oil (UNII: 724GKU717M)
INGR	laureth-7 (UNII: Z95S6G8201)
INGR	starch, corn (UNII: O8232NY3SJ)
INGR	polysorbate 20 (UNII: 7T1F30V5YH)
INGR	dimethicone (UNII: 92RU3N3Y1O)
INGR	lauroyl lysine (UNII: 113171Q70B)
INGR	octinoxate (UNII: 4Y5P7MUD51)
INGR	magnesium aluminum silicate (UNII: 6M3P64V0NC)
INGR	c13-14 isoparaffin (UNII: E4F12ROE70)
INGR	cetearyl ethylhexanoate (UNII: 9M64UO4C25)
INGR	sorbitan monostearate (UNII: NVZ4I0H58X)
INGR	isopropyl myristate (UNII: 0RE8K4LNJS)
INGR	butylated hydroxytoluene (UNII: 1P9D0Z171K)
INGR	sodium dehydroacetate (UNII: 8W46YN971G)
INGR	phenoxyethanol (UNII: HIE492ZZ3T)
INGR	mica (UNII: V8A1AW0880)
INGR	titanium dioxide (UNII: 15FIX9V2JP)
INGR	ferric oxide red (UNII: 1K09F3G675)
INGR	ferric oxide yellow (UNII: EX438O2MRT)
INGR	ferrosoferric oxide (UNII: XM0M87F357)
INGR	bismuth oxychloride (UNII: 4ZR792I587)
INGR	fd&c blue no. 1 (UNII: H3R47K3TBD)
INGR	carminic acid (UNII: CID8Z8N95N)
INGR	chromium hydroxide green (UNII: RV8FT8XF5R)
INGR	chromic oxide (UNII: X5Z09SU859)
INGR	ferric ferrocyanide (UNII: TLE294X33A)
INGR	manganese violet (UNII: 72M48QQV8Q)
INGR	d&c red no. 6 (UNII: 481744AI4O)
INGR	d&c red no. 7 (UNII: ECW0LZ41X8)
INGR	fd&c yellow no. 5 (UNII: I753WB2F1M)
INGR	fd&c yellow no. 6 (UNII: H77VEI93A8)
INGR	ultramarine blue (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		9 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/31/2013

Labeler - Stila Styles, LLC (809192896)

Establishment
Name	Address	ID/FEI	Business Operations
GORDON LABORATORIES, INC.		008328619	MANUFACTURE(76049-620)