ILLUSION TINTED MOISTURIZER BROAD SPECTRUM SABLE SPF 15- octinoxate, octisalate, titanium dioxide emulsion

Illusion Tinted Moisturizer Broad Spectrum Sable by

Drug Labeling and Warnings

Illusion Tinted Moisturizer Broad Spectrum Sable by is a Otc medication manufactured, distributed, or labeled by Kingdom Animalia, LLC DBA Hourglass Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate  7.0%

Octisalate 4.0%

Titanium Dioxide 4.0%

Purpose

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

• Apply liberally 15 minutes before sun exposure.
• Use a 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 of 15 or higher and other skin protection measures including:

• Limit time in the sun, especially from 10 a.m. – 2 p.m.
• Wear long-sleeve shirts, pants, hats and sunglasses.

Children under 6 months: Ask a doctor

Inactive Ingredients

ALUMINA, BUTYLENE GLYCOL, CALCIUM CARBONATE, CAPRYLYL GLYCOL, CETYL PEG/PPG 10/1 DIMETHICONE, ETHYLHEXYL PALMITATE, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL BEHENATE, GLYCERYL DIBEHENATE, GOSSYPIUM HERBACEUM(COTTON), HEXYL LAURATE, HEXYLENE GLYCOL, HYDROGENATED POLYISOBUTENE, LYCIUM BARBARUM FRUIT EXTRACT, MAGNESIUM SULFATE, MICA, MICROCRYSTALLINE WAX, PEG-10 DIMETHICONE, PENTAERYTHRITYL, TETRASISOSTERATE, PHENOXYETHANOL, POLYETHYLACRYLATE, POLYGLYCERYL-3 BEESWAX, POLYGLYCERYL-3 POLYRICINOLEATE, POLYGLYCERYL-4 ISOSTEARATE, POTASSIUM SORBATE, PROPYLENE CARBONATE, QUATERNIUM-90 BENTONITE, SILICA, SILICA DIMETHYL SILYLATE, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYALURONATE, STEARIC ACID, TREBEHENIN, TRIETHOXYLCAPRYLYLSILANE, WATER. MAY CONTAIN (+/-): IRON OXIDES (CI77491), IRON OXIDES (CI77492), IRON OXIDES (CI77499), TITANIUM DIOXIDE (CI77891).

Other information

Protect this product from excessive heat and direct sun.

Questions or Comments?

Call toll free 855-201-4529

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ILLUSION TINTED MOISTURIZER BROAD SPECTRUM SABLE  SPF 15
octinoxate, octisalate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42627-259
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CALCIUM CARBONATE (UNII: H0G9379FGK)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
GOSSYPIUM HERBACEUM WHOLE (UNII: 9DK7DJK0D6)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42627-259-02	1 in 1 CARTON	07/01/2014
1	NDC: 42627-259-01	30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2014

Labeler - Kingdom Animalia, LLC DBA Hourglass Cosmetics (004924553)