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AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29C

67225-5216 AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29C

Approved
Approval ID

15536331-fec5-4daa-824d-2e32d63e6452

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Aekyung Industrial Co., Ltd.

DUNS: 690511126

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Octinoxate, Octocrylene, Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67225-5216
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Octinoxate, Octocrylene, Titanium Dioxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (54)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
BETULA PLATYPHYLLA JAPONICA JUICEInactive
Code: 1B33PG6N4K
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST)Inactive
Code: P0TX083987
Classification: IACT
PHENYL TRIMETHICONEInactive
Code: DR0K5NOJ4R
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
EUPHORBIA CERIFERA (CANDELILLA) WAXInactive
Code: WL0328HX19
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
ALOE BARBADENSIS LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
TRIISOSTEARINInactive
Code: 71503RH8KG
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
ISODECYL NEOPENTANOATEInactive
Code: W60VYE24XC
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
VP/HEXADECENE COPOLYMERInactive
Code: KFR5QEN0N9
Classification: IACT
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)Inactive
Code: V2W71V8T0X
Classification: IACT
SODIUM GLUTAMATEInactive
Code: W81N5U6R6U
Classification: IACT
C30-45 ALKYL METHICONEInactive
Code: NFX970DSI2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
P-ANISIC ACIDInactive
Code: 4SB6Y7DMM3
Classification: IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive
Code: 21AS8B1BSS
Classification: IACT
C30-45 OLEFINInactive
Code: 6DWD51M0O8
Classification: IACT
GLYCERYL CAPRYLATEInactive
Code: TM2TZD4G4A
Classification: IACT
BETULA PLATYPHYLLA JAPONICA BARKInactive
Code: ZF70YKN0YO
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive
Code: Z570VEV8XK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, D-Inactive
Code: A7E6112E4N
Classification: IACT
CERAMIDE NPInactive
Code: 4370DF050B
Classification: IACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive
Code: EG97988M5Q
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARYL HEPTANOATEInactive
Code: 2M4UGL1NCN
Classification: IACT
ADENOSINEInactive
Code: K72T3FS567
Classification: IACT
HYALURONIC ACIDInactive
Code: S270N0TRQY
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
LIMOSILACTOBACILLUS FERMENTUM ME-3Inactive
Code: BQX4W45LG8
Classification: IACT
HAEMATOCOCCUS PLUVIALISInactive
Code: 31T0FF0472
Classification: IACT
LINOLEIC ACIDInactive
Code: 9KJL21T0QJ
Classification: IACT
BHTInactive
Code: 1P9D0Z171K
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
BORON NITRIDEInactive
Code: 2U4T60A6YD
Classification: IACT
ASTAXANTHINInactive
Code: 8XPW32PR7I
Classification: IACT
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATEInactive
Code: 255PIF62MS
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
CI 77492Inactive
Code: EX438O2MRT
Classification: IACT
CI 77491Inactive
Code: 1K09F3G675
Classification: IACT
CI 77499Inactive
Code: XM0M87F357
Classification: IACT
OCTOCRYLENEActive
Quantity: 0.42 g in 14 g
Code: 5A68WGF6WM
Classification: ACTIB
TITANIUM DIOXIDEActive
Quantity: 0.7186 g in 14 g
Code: 15FIX9V2JP
Classification: ACTIB
OCTINOXATEActive
Quantity: 0.91 g in 14 g
Code: 4Y5P7MUD51
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/13/2025

AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29C

PDP

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/13/2025

■ 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.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/13/2025

if ■ rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/13/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/13/2025

Octinoxate 6.50%
Octocrylene 3.00%
Titanium Dioxide 5.12%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/13/2025

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 8/13/2025

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/13/2025

■ damaged skin or broken skin

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/13/2025

■ keep out of eyes. Rinse with water to remove.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/13/2025

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, DISODODECANE, 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, YDROXYHYDROCINNAMATE, 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

LOINC: 60561-8Updated: 8/13/2025

■ Protect the product in the container from excessive heat and avoid storing it under direct sun.

■ 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 SECTION

LOINC: 34068-7Updated: 8/13/2025

Directions

■ 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.

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AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29C - FDA Drug Approval Details