AGE 20S SIGNATURE ESSENCE PACT INTENSE COVER 31N- octinoxate, octocrylene, titanium dioxide cream

AGE 20s SIGNATURE ESSENCE PACT INTENSE COVER 31N by

Drug Labeling and Warnings

AGE 20s SIGNATURE ESSENCE PACT INTENSE COVER 31N by is a Otc medication manufactured, distributed, or labeled by Aekyung Industrial Co., Ltd., Aekyung Industrial Co., Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 6.50 %

Octocrylene 3.00 %

Titanium Dioxide 5.12 %

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn.

WARNINGS

For external use only.

DO NOT USE

damaged skin or broken skin.

WHEN USING

keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

■ Apply the product on your skin with the included applicator by rubbing the product with the applicator and gently patting it on your 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.

STORAGE AND HANDLING

■ 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 INGREDIENT

Betula Platyphylla Japonica Bark Extract, Betula Platyphylla Japonica Juice, Dipropylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Phenyl Trimethicone, Niacinamide, Hydrogenated Poly(C6-14 Olefin), Euphorbia Cerifera (Candelilla) Wax, Dimethicone, Cyclopentasiloxane, Butylene Glycol, Squalane, Aloe Barbadensis Leaf Extract, Triisostearin, 1,2-Hexanediol, Cyclohexasiloxane, Polymethylsilsesquioxane, Propanediol, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Glutamate, VP/Hexadecene Copolymer, Aluminum Hydroxide, C30-45 Alkyl Methicone, p-Anisic Acid, Dimethicone/PEG-10/15 Crosspolymer, Stearic Acid, C30-45 Olefin, Glyceryl Caprylate, Glycerin, Triethoxycaprylylsilane, Alumina, Tocopheryl Acetate, Panthenol, Ceramide NP, Stearyl Heptanoate, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Adenosine, Cholesterol, Water, Sodium Hyaluronate, Polyhydroxystearic Acid, Hydrolyzed Hyaluronic Acid, Lactobacillus Ferment Lysate, Haematococcus Pluvialis Extract, Linoleic Acid, Boron Nitride, Astaxanthin, Aphanothece Sacrum Polysaccharide, Glycine Soja (Soybean) Oil, Lecithin, Ethylhexylglycerin, sh-Polypeptide-60, Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Benzyl Salicylate, Linalool, +/- may contain (Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499))

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AGE 20S SIGNATURE ESSENCE PACT INTENSE COVER 31N 
octinoxate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-5331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.91 g  in 14 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.42 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.7168 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)
CERAMIDE NP (UNII: 4370DF050B)
BETULA PLATYPHYLLA BARK (UNII: ZF70YKN0YO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SOYBEAN OIL (UNII: 241ATL177A)
ASTAXANTHIN (UNII: 8XPW32PR7I)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
TRIISOSTEARIN (UNII: 71503RH8KG)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
C30-45 OLEFIN (UNII: 6DWD51M0O8)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
SQUALANE (UNII: GW89575KF9)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
STEARIC ACID (UNII: 4ELV7Z65AP)
PANTHENOL (UNII: WV9CM0O67Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CANDELILLA WAX (UNII: WL0328HX19)
HYALURONIC ACID (UNII: S270N0TRQY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BETULA PLATYPHYLLA VAR. JAPONICA RESIN (UNII: 1B33PG6N4K)
ALUMINUM OXIDE (UNII: LMI26O6933)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BORON NITRIDE (UNII: 2U4T60A6YD)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
ADENOSINE (UNII: K72T3FS567)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-5331-2	2 in 1 PACKAGE	10/11/2024
1		14 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	10/11/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Industrial Co., Ltd.		690511126	manufacture(67225-5331)