LIGHT ILLUSION LUMINOUS MAKEUP NUDE-SKIN FEEL SPF18 SHELL- octinoxate, titanium dioxide, zinc oxide cream

Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELL by

Drug Labeling and Warnings

Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELL by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, INC, COSMAX USA, CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Octinoxate 5%

Titanium Dioxide 2%

Zinc Oxide 4.9%

PURPOSE

Purpose

Sunscreen

USES

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

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

Drections

For sunscreen use:

• Apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• 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 broad spectrum SPF of 15 or higher and other sun 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 of age: Ask a doctor

OTHER INFORMATION

Other information

• Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients: Water, Ethylhexyl Palmitate, Butylene Glycol, Caprylic/Capric Triglyceride, Butylene Glycol Dicaprylate/Dicaprate, Glycerin, Neopentyl Glycol Diethylhexanoate, Cetyl Ethylhexanoate, PEG-30 Dipolyhydroxystearate, Pentylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Polymethyl Methacrylate, PEG-10 Dimethicone, Cyclopentasiloxane, Phenoxyethanol, Magnesium Sulfate, Sorbitan Isostearate, Beeswax, Stearalkonium Hectorite, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Dimethicone, Ethylhexylglycerin, Disodium EDTA. May Contain: Titanium Dioxide, Iron Oxides, Mica.

Packaging Label

INGREDIENTS AND APPEARANCE

LIGHT ILLUSION LUMINOUS MAKEUP NUDE-SKIN FEEL SPF18 SHELL 
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-174
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 mg  in 100 mg
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM SULFATE (UNII: DE08037SAB)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BEESWAX (UNII: 2ZA36H0S2V)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
FERROUS OXIDE (UNII: G7036X8B5H)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-174-00	30 mg in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/15/2018

Labeler - COSMAX USA, INC (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORPORATION		010990210	manufacture(68577-174)