AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N- octinoxate, octocrylene, titanium dioxide cream

AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N by

Drug Labeling and Warnings

AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N by is a Otc medication manufactured, distributed, or labeled by 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

WARNINGS

For external use only

INDICATIONS & USAGE

■ 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.

DO NOT USE

■ damaged skin or broken skin

WHEN USING

■ 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 poison control center right away.

INACTIVE INGREDIENT

WATER (AQUA)
ETHYLHEXYL METHOXYCINNAMATE
TITANIUM DIOXIDE (NANO)
BETULA PLATYPHYLLA JAPONICA JUICE
DIPROPYLENE GLYCOL
PENTAERYTHRITYL STEARATE/CAPRATE/CAPRYLATE/ADIPATE
HYDROGENATED POLY(C6-14 OLEFIN)
OCTOCRYLENE
PHENYL TRIMETHICONE
NIACINAMIDE
EUPHORBIA CERIFERA (CANDELILLA) WAX
DIMETHICONE
BUTYLENE GLYCOL
ALOE BARBADENSIS LEAF EXTRACT
TRIISOSTEARIN
1,2-HEXANEDIOL
ISODODECANE
POLYMETHYLSILSESQUIOXANE
ISODECYL NEOPENTANOATE
PROPANEDIOL
VP/HEXADECENE COPOLYMER
ALUMINUM HYDROXIDE
CETYL PEG/PPG-10/1 DIMETHICONE
SODIUM GLUTAMATE
C30-45 ALKYL METHICONE
STEARIC ACID
P-ANISIC ACID
DIMETHICONE/PEG-10/15 CROSSPOLYMER
C30-45 OLEFIN
GLYCERYL CAPRYLATE
BETULA PLATYPHYLLA JAPONICA BARK EXTRACT
GLYCERIN
TRIETHOXYCAPRYLYLSILANE
PANTHENOL
TOCOPHERYL ACETATE
CERAMIDE NP
METHYL METHACRYLATE CROSSPOLYMER
STEARYL HEPTANOATE
ADENOSINE
SILICA
HYDROLYZED HYALURONIC ACID
POLYHYDROXYSTEARIC ACID
SODIUM HYALURONATE
LACTOBACILLUS FERMENT LYSATE
HAEMATOCOCCUS PLUVIALIS EXTRACT
LINOLEIC ACID
BHT
SODIUM CITRATE
BORON NITRIDE
ASTAXANTHIN
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE
TOCOPHEROL
APHANOTHECE SACRUM POLYSACCHARIDE
FRAGRANCE (PARFUM)
Titanium Dioxide(CI 77891)
IRON OXIDES (CI 77492)
IRON OXIDES (CI 77491)
IRON OXIDES (CI 77499)

OTHER SAFETY INFORMATION

■ Protect the product in the 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.

DOSAGE & ADMINISTRATION

■ Apply liberally 15 minutes before sun exposure.
■ Children under 6 months of age: Ask a doctor.
■ 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. Todecrease 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N 
octinoxate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-5211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.42 g  in 14 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.91 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
BETULA PLATYPHYLLA JAPONICA JUICE (UNII: 1B33PG6N4K)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
PANTHENOL (UNII: WV9CM0O67Z)
BORON NITRIDE (UNII: 2U4T60A6YD)
ASTAXANTHIN (UNII: 8XPW32PR7I)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIISOSTEARIN (UNII: 71503RH8KG)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
BHT (UNII: 1P9D0Z171K)
GLYCERIN (UNII: PDC6A3C0OX)
CERAMIDE NP (UNII: 4370DF050B)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
SODIUM GLUTAMATE (UNII: W81N5U6R6U)
CI 77492 (UNII: EX438O2MRT)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CI 77499 (UNII: XM0M87F357)
C30-45 OLEFIN (UNII: 6DWD51M0O8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ISODODECANE (UNII: A8289P68Y2)
STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ADENOSINE (UNII: K72T3FS567)
STEARIC ACID (UNII: 4ELV7Z65AP)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CI 77491 (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-5211-2	1 in 1 PACKAGE	08/12/2025
1	NDC: 67225-5211-1	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	08/12/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Industrial Co., Ltd.		690511126	manufacture(67225-5211)