COLOR CORRECTING PRIMER PURPLE- octinoxate, zinc oxide, titanium dioxide cream

COLOR CORRECTING PRIMER PURPLE by

Drug Labeling and Warnings

COLOR CORRECTING PRIMER PURPLE by is a Otc medication manufactured, distributed, or labeled by Inel Cosmetics Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethylhexyl Methoxycinnamate 5%
Zinc Oxide 4.9%
Titanium Dioxide 4.15%

PURPOSE

Sunscreen

INSTRUCTIONS FOR USE

For sunscreen use:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every two hours

- Use a water resistant sunscreen if swimming or sweating

ASK DOCTOR

If rash or irritation occurs, stop use and ask a doctor.

WHEN USING

When using this product, keep out of eyes. Rinse with water to remove.

INACTIVE INGREDIENT

Water
Cyclopentasiloxane
Diphenylsiloxy Phenyl Trimethicone
Glycerin
Butylene Glycol Dicaprylate/Dicaprate
Cyclohexasiloxane
Butylene Glycol
Niacinamide
Cetyl PEG/PPG-10/1 Dimethicone
Pentylene Glycol
Sorbitan Isostearate
Hexyldecyl Myristoyl Methylaminopropionate
Hexyl Laurate
Disteardimonium Hectorite
Magnesium Sulfate
Ultramarines (CI 77007)
Methyl Methacrylate Crosspolymer
Tribehenin
Dimethicone
PEG-10 Dimethicone
Phenoxyethanol
Glyceryl Tribehenate/Isostearate/Eicosandioate
Aluminum Hydroxide
Stearic Acid
Dimethiconol
Fragrance(Parfum)
Dimethicone Crosspolymer
Triethoxycaprylylsilane
Ethylhexylglycerin
Adenosine
Disodium EDTA
Acacia Senegal Gum
Rosa Damascena Flower Oil
Rosa Gallica Flower Extract
Hydrolyzed Rhizobian Gum
Ascorbyl Tetraisopalmitate
Sodium PCA
Urea
Trehalose
Gold (CI 77480)
Polyquaternium-51
Hexylene Glycol
Caprylyl Glycol
Triacetin
Sodium Hyaluronate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLOR CORRECTING PRIMER PURPLE 
octinoxate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43526-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 mg  in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.96 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.66 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE (UNII: 1959TW0O9A)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ULTRAMARINE BLUE (UNII: I39WR998BI)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE (UNII: 3Y9NJ5Z7E5)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ACACIA (UNII: 5C5403N26O)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
ROSA GALLICA FLOWER (UNII: X8W61WUV70)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
UREA (UNII: 8W8T17847W)
TREHALOSE (UNII: B8WCK70T7I)
GOLD (UNII: 79Y1949PYO)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1) (UNII: X8Q92E1CPM)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIACETIN (UNII: XHX3C3X673)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43526-123-02	1 in 1 CARTON	01/31/2018
1	NDC: 43526-123-01	40 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	01/31/2018

Labeler - Inel Cosmetics Co., Ltd. (688038939)

Registrant - Inel Cosmetics Co., Ltd. (688038939)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(43526-123)