STILA ILLUMINATE AND SHINE- octinoxate, avobenzoate, and octisalate 
Stila Styles, LLC

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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stila illuminate and shine

illuminating tinted moisturizer - shade 01

Drug Facts

Active IngredientsPurpose
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>

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

Principal Display Panel - Kit Label
STILA ILLUMINATE AND SHINE 
octinoxate, avobenzoate, and octisalate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76049-620
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76049-620-011 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 50 mL
Part 21 TUBE 10 mL
Part 31 CONTAINER 9 g
Part 1 of 3
ILLUMINATED TINTED MOISTURIZER   SHADE 01
octinoxate, avobenzone, and octisalate lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/31/2013
Part 2 of 3
ONE STEP PRIMECOLOR   KITTEN
foundations lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRdimethicone (UNII: 92RU3N3Y1O)  
INGRwater (UNII: 059QF0KO0R)  
INGRisododecane (UNII: A8289P68Y2)  
INGRhydrogenated didecene (UNII: 048B98MT5O)  
INGRsilicon dioxide (UNII: ETJ7Z6XBU4)  
INGRsilica dimethyl silylate (UNII: EU2PSP0G0W)  
INGRglycerin (UNII: PDC6A3C0OX)  
INGRdisteardimonium hectorite (UNII: X687XDK09L)  
INGRtribehenin (UNII: 8OC9U7TQZ0)  
INGRphenoxyethanol (UNII: HIE492ZZ3T)  
INGRtropolone (UNII: 7L6DL16P1T)  
INGRtalc (UNII: 7SEV7J4R1U)  
INGRsodium dehydroacetate (UNII: 8W46YN971G)  
INGRedetate disodium (UNII: 7FLD91C86K)  
INGRtriethoxycaprylylsilane (UNII: LDC331P08E)  
INGRkaolin (UNII: 24H4NWX5CO)  
INGRmontmorillonite (UNII: A585MN1H2L)  
INGRmica (UNII: V8A1AW0880)  
INGRtitanium dioxide (UNII: 15FIX9V2JP)  
INGRferric oxide red (UNII: 1K09F3G675)  
INGRferric oxide yellow (UNII: EX438O2MRT)  
INGRferrosoferric oxide (UNII: XM0M87F357)  
INGRcarminic acid (UNII: CID8Z8N95N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC
Part 3 of 3
ILLUMINATING FINISHING POWDER   GOLD
face powders powder
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRtalc (UNII: 7SEV7J4R1U)  
INGRoctyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)  
INGR.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
INGRvitamin a palmitate (UNII: 1D1K0N0VVC)  
INGRjojoba oil (UNII: 724GKU717M)  
INGRlaureth-7 (UNII: Z95S6G8201)  
INGRstarch, corn (UNII: O8232NY3SJ)  
INGRpolysorbate 20 (UNII: 7T1F30V5YH)  
INGRdimethicone (UNII: 92RU3N3Y1O)  
INGRlauroyl lysine (UNII: 113171Q70B)  
INGRoctinoxate (UNII: 4Y5P7MUD51)  
INGRmagnesium aluminum silicate (UNII: 6M3P64V0NC)  
INGRc13-14 isoparaffin (UNII: E4F12ROE70)  
INGRcetearyl ethylhexanoate (UNII: 9M64UO4C25)  
INGRsorbitan monostearate (UNII: NVZ4I0H58X)  
INGRisopropyl myristate (UNII: 0RE8K4LNJS)  
INGRbutylated hydroxytoluene (UNII: 1P9D0Z171K)  
INGRsodium dehydroacetate (UNII: 8W46YN971G)  
INGRphenoxyethanol (UNII: HIE492ZZ3T)  
INGRmica (UNII: V8A1AW0880)  
INGRtitanium dioxide (UNII: 15FIX9V2JP)  
INGRferric oxide red (UNII: 1K09F3G675)  
INGRferric oxide yellow (UNII: EX438O2MRT)  
INGRferrosoferric oxide (UNII: XM0M87F357)  
INGRbismuth oxychloride (UNII: 4ZR792I587)  
INGRfd&c blue no. 1 (UNII: H3R47K3TBD)  
INGRcarminic acid (UNII: CID8Z8N95N)  
INGRchromium hydroxide green (UNII: RV8FT8XF5R)  
INGRchromic oxide (UNII: X5Z09SU859)  
INGRferric ferrocyanide (UNII: TLE294X33A)  
INGRmanganese violet (UNII: 72M48QQV8Q)  
INGRd&c red no. 6 (UNII: 481744AI4O)  
INGRd&c red no. 7 (UNII: ECW0LZ41X8)  
INGRfd&c yellow no. 5 (UNII: I753WB2F1M)  
INGRfd&c yellow no. 6 (UNII: H77VEI93A8)  
INGRultramarine blue (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
19 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/31/2013
Labeler - Stila Styles, LLC (809192896)
Establishment
NameAddressID/FEIBusiness Operations
GORDON LABORATORIES, INC.008328619MANUFACTURE(76049-620)

Revised: 11/2013
Document Id: 2b674434-a7bf-4d46-88b9-29cfbc5cfdf7
Set id: aaa27998-0db4-4884-80f7-43c9bc6815a9
Version: 1
Effective Time: 20131125
 
Stila Styles, LLC