AEKYUNGLUNA LONG LASTING CONCEAL FIXING CUSHION 21C COOL IVORY- titanium dioxide, zinc oxide cream

AEKYUNGLUNA LONG LASTING CONCEAL FIXING CUSHION 21C COOL IVORY by

Drug Labeling and Warnings

AEKYUNGLUNA LONG LASTING CONCEAL FIXING CUSHION 21C COOL IVORY by is a Otc medication manufactured, distributed, or labeled by Aekyung Industrial Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 6.64%

Zinc Oxide 6.83%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

Do not use on

damaged skin 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 swallowed, get medical help or contact a poison control center right away.

Directions

• Apply an adequate amount and spread evenly on the skin.
• Apply liberally 15 minutes before sun exposure.

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 value 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-sleeved shirts, pants, hats, and sunglasses

• Children under 6 months of age: Ask a doctor.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.

Other information

• Protect the product in this container from excessive heat and avoid storing it under direct sun.
• Do not crush or drop product.
• Handle with care.
• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, Cyclopentasiloxane, Isododecane, Dimethicone, Butylene Glycol, Silica, Phenyl Trimethicone, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Niacinamide, Acrylates/Dimethicone Copolymer, Sodium Chloride, Mica, Stearic Acid, Aluminum Hydroxide, 1,2-Hexanediol, PEG-10 Dimethicone, Aloe Barbadensis Leaf Extract, Disteardimonium Hectorite, p-Anisic Acid, Triethoxycaprylylsilane, PPG-17/IPDI/DMPA Copolymer, Propanediol, Dimer Dilinoleyl Diisostearate, Glyceryl Caprylate, Palmitic Acid, PEG/PPG-10/30 Copolymer, Glycerin, Adenosine, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Chamaecyparis Obtusa Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract, Pinus Koraiensis Seed Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Pinus Sylvestris Cone Extract, Limonene, Linalool, Fragrance, +/- may contain (Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499))

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AEKYUNGLUNA LONG LASTING CONCEAL FIXING CUSHION 21C COOL IVORY 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-3020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.8196 g  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.7968 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 7 (UNII: KCK5L8VU47)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
NIACINAMIDE (UNII: 25X51I8RD4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ROSEMARY (UNII: IJ67X351P9)
LINALOOL, (+)- (UNII: F4VNO44C09)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ADENOSINE (UNII: K72T3FS567)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
DIMER DILINOLEYL DIISOSTEARATE (UNII: A4788E5790)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CHAMOMILE (UNII: FGL3685T2X)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
PINUS KORAIENSIS SEED OIL (UNII: 08F703RHY3)
PINUS SYLVESTRIS CONE (UNII: 856B44M480)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPANEDIOL (UNII: 5965N8W85T)
PALMITIC ACID (UNII: 2V16EO95H1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-3020-2	2 in 1 BOX	06/09/2022
1	NDC: 67225-3020-1	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/09/2022

Labeler - Aekyung Industrial Co., Ltd. (690511126)

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Industrial Co., Ltd.		690511126	manufacture(67225-3020)