AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL- octinoxate, titanium dioxide, octocrylene cream

AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL by

Drug Labeling and Warnings

AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL 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%

Titanium Dioxide 5.12%

Octocrylene 3.00%

PURPOSE

Sunscreen

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.

WARNINGS

For external use only

DO NOT USE

■ damaged skin or broken skin

WHEN USING

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

STOP USE

and ask a doctor ■ rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

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

Directions
■ 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 10a.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.

INACTIVE INGREDIENT

Water, Betula Platyphylla Japonica Juice, Dipropylene Glycol, Pentaerythrityl Stearate/Caprate/Caprylate/Adipate, Phenyl Trimethicone, Polymethylsilsesquioxane, Hydrogenated Poly(C6-14 Olefin), Niacinamide, Euphorbia Cerifera (Candelilla) Wax, Dimethicone, Cyclopentasiloxane, Butylene Glycol, Aloe Barbadensis Leaf Extract, Squalane, Triisostearin, 1,2-Hexanediol, Cyclohexasiloxane, Propanediol, Cetyl PEG/PPG-10/1 Dimethicone, Aluminum Hydroxide, Sodium Glutamate, VP/Hexadecene Copolymer, 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, Fragrance, Triethoxycaprylylsilane, Panthenol, Tocopheryl Acetate, Ceramide NP, Stearyl Heptanoate, Adenosine, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Cholesterol, Hydrolyzed Hyaluronic Acid, Polyhydroxystearic Acid, Sodium Hyaluronate, Lactobacillus Ferment Lysate, Linoleic Acid, BHT, Sodium Citrate, Boron Nitride, Tocopherol, Aphanothece Sacrum Polysaccharide, Glycine Soja (Soybean) Oil, Ethylhexylglycerin, Lecithin, Disodium EDTA, Sodium Ascorbyl Phosphate, sh-Polypeptide-60, Alpha-Isomethyl Ionone, Benzyl Benzoate, Benzyl Salicylate, Linalool, +/- may contain (Titanium Dioxide (CI 77891), Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499))

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL 
octinoxate, titanium dioxide, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-5231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.7168 g  in 14 g
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

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
WATER (UNII: 059QF0KO0R)
PANTHENOL (UNII: WV9CM0O67Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
CERAMIDE NP (UNII: 4370DF050B)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PENTAERYTHRITYL STEARATE (UNII: T9BY3B181Z)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ADENOSINE (UNII: K72T3FS567)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYALURONIC ACID (UNII: S270N0TRQY)
CHOLESTEROL (UNII: 97C5T2UQ7J)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
BETULA PLATYPHYLLA RESIN (UNII: 1B33PG6N4K)
CANDELILLA WAX (UNII: WL0328HX19)
SQUALANE (UNII: GW89575KF9)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
TOCOPHEROL (UNII: R0ZB2556P8)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TRIISOSTEARIN (UNII: 71503RH8KG)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
BORON NITRIDE (UNII: 2U4T60A6YD)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
C30-45 OLEFIN (UNII: 6DWD51M0O8)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-5231-2	1 in 1 BOX	02/22/2024
1	NDC: 67225-5231-1	40 g in 1 TUBE; 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	02/22/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Industrial Co., Ltd.		690511126	manufacture(67225-5231)