67225-5309 Age20s Signature Essence Pact Intense Cover Mini 41n

67225-5309 Age20s Signature Essence Pact Intense Cover Mini 41n
SPL v1
SPL
SPL Set ID 43d5299f-6273-30ab-e063-6294a90a082e
Route
TOPICAL
Published
Effective Date 2025-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (0.12 g) Titanium Dioxide (0.2048 g) Octinoxate (0.26 g)
Inactive Ingredients
Water Betula Platyphylla Japonica Juice Dipropylene Glycol Hydrogenated Poly(c6-14 Olefin; 2 Cst) Phenyl Trimethicone Niacinamide Euphorbia Cerifera (candelilla) Wax Dimethicone Butylene Glycol Aloe Barbadensis Leaf Triisostearin 1,2-hexanediol Isododecane Isodecyl Neopentanoate Propanediol Vp/hexadecene Copolymer Aluminum Hydroxide Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) 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 Triethoxycaprylylsilane Polymethylsilsesquioxane (11 Microns) Glycerin Panthenol Silica .alpha.-tocopherol Acetate, D- Ceramide Np Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Stearyl Heptanoate Adenosine Hyaluronic Acid Polyhydroxystearic Acid (2300 Mw) Sodium Hyaluronate Limosilactobacillus Fermentum Me-3 Haematococcus Pluvialis Linoleic Acid Bht Sodium Citrate Boron Nitride Astaxanthin Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Tocopherol Ci 77492 Ci 77491 Ci 77499

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-17

Description

Octinoxate 6.50% Octocrylene 3.00% Titanium Dioxide 5.12%


Medication Information

Warnings and Precautions

For external use only

Indications and 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.

Description

Octinoxate 6.50% Octocrylene 3.00% Titanium Dioxide 5.12%

Section 50565-1

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

Section 50566-9

if ■ rash occurs.

Section 50567-7

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

Section 50570-1

■ damaged skin or broken skin

Section 51727-6

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)

Section 55105-1

Sunscreen

Section 55106-9

Octinoxate 6.50%

Octocrylene 3.00%

Titanium Dioxide 5.12%

Section 60561-8

■ 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.

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.

Age20s Signature Essence Pact Intense Cover Mini 41n


Structured Label Content

Indications and Usage (34067-9)

■ 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 and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

if ■ rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

■ damaged skin or broken skin

Section 51727-6 (51727-6)

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)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Octinoxate 6.50%

Octocrylene 3.00%

Titanium Dioxide 5.12%

Section 60561-8 (60561-8)

■ 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.

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.

Age20s Signature Essence Pact Intense Cover Mini 41n (AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 41N)


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