[de-listing] AEKYUNGLUNA LONG LASTING CONCEAL FIXING CUSHION MEDIUM BEIGE 23M 67225-2104-2

AEKYUNGLUNA LONG LASTING CONCEAL FIXING CUSHION MEDIUM BEIGE 23M by

Drug Labeling and Warnings

AEKYUNGLUNA LONG LASTING CONCEAL FIXING CUSHION MEDIUM BEIGE 23M by is a Otc medication manufactured, distributed, or labeled by Aekyung Industrial Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AEKYUNGLUNA LONG LASTING CONCEAL FIXING CUSHION MEDIUM BEIGE 23M- titanium dioxide, zinc oxide cream 
Aekyung Industrial Co., Ltd.

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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[de-listing] AEKYUNGLUNA LONG LASTING CONCEAL FIXING CUSHION MEDIUM BEIGE 23M
67225-2104-2

Active ingredients

Titanium dioxide 12.07 %
Zinc oxide 6.83 %

Stop use and ask a doctor

if rash occurs

Do not use

on damaged skin or broken skin

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

When using this product

keep out of eyes. Rinse with water to remove.

Warnings

For external use only.

Inactive ingredients

Water, Cyclopentasiloxane, Isododecane, Dimethicone, Butylene Glycol, Silica, Phenyl Trimethicone,

Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Niacinamide, Acrylates/Dimethicone Copolymer,

Sodium Chloride, 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, Fragrance, Mica,

May contain: Iron Oxides (CI 77492, CI 77491, CI 77499)

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.

Uses

Helps prevent sunburn

Directions

■ Apply the contents to the puff and pat it 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
sunprotection measuring 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.

AEKYUNGLUNA LONG LASTING CONCEAL FIXING CUSHION MEDIUM BEIGE 23M 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-2104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.8 g  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.4 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
STEARIC ACID (UNII: 4ELV7Z65AP)
ADENOSINE (UNII: K72T3FS567)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
PINUS SYLVESTRIS CONE (UNII: 856B44M480)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMER DILINOLEYL DIISOSTEARATE (UNII: A4788E5790)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
PALMITIC ACID (UNII: 2V16EO95H1)
GLYCERIN (UNII: PDC6A3C0OX)
CHAMOMILE (UNII: FGL3685T2X)
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPANEDIOL (UNII: 5965N8W85T)
PINUS KORAIENSIS SEED OIL (UNII: 08F703RHY3)
ROSEMARY (UNII: IJ67X351P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-2104-2	2 in 1 BOX	03/23/2021
1	NDC: 67225-2104-1	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 not final	part352	03/23/2021	03/20/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Industrial Co., Ltd.		690511126	manufacture(67225-2104)

Revised: 3/2023

Document Id: f765b365-2be9-ac55-e053-6294a90a1d44

34390-5

Set id: be6a0af0-afbf-6e93-e053-2995a90a8982

Version: 2

Effective Time: 20230321