67225-5211 Age20s Signature Essence Pact Intense Cover 17n

67225-5211 Age20s Signature Essence Pact Intense Cover 17n
SPL v4
SPL
SPL Set ID 3c295f6b-6202-a2e1-e063-6394a90a9a60
Route
TOPICAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (0.42 g) Octinoxate (0.91 g) Titanium Dioxide (0.7168 g)
Inactive Ingredients
Betula Platyphylla Japonica Juice Dipropylene Glycol Niacinamide Propanediol Panthenol Boron Nitride Astaxanthin Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Butylene Glycol Dimethicone Triisostearin 1,2-hexanediol Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) C30-45 Alkyl Methicone Sodium Hyaluronate Triethoxycaprylylsilane Hydrogenated Poly(c6-14 Olefin; 2 Cst) Vp/hexadecene Copolymer Bht Glycerin Ceramide Np Polymethylsilsesquioxane (11 Microns) Euphorbia Cerifera (candelilla) Wax Sodium Glutamate Ci 77492 Linoleic Acid Ci 77499 C30-45 Olefin Polyhydroxystearic Acid (2300 Mw) Phenyl Trimethicone Isododecane Stearyl Heptanoate Sodium Citrate Isodecyl Neopentanoate Aluminum Hydroxide Adenosine Stearic Acid P-anisic Acid Tocopherol Dimethicone/peg-10/15 Crosspolymer Glyceryl Caprylate Ci 77491 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-12

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.

Dosage and 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.

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

and ask a doctor 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

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)

Section 51945-4

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.

■ 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.


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.

Dosage and Administration (34068-7)



■ 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.

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)

and ask a doctor 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

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)

Section 51945-4 (51945-4)

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.

■ 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.


Advanced Ingredient Data


Raw Label Data

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