67225-5301 Age20s Uv Mineral Priming Sunscreen

67225-5301 Age20s Uv Mineral Priming Sunscreen
SPL v1
SPL
SPL Set ID 43c1f70b-0664-40be-e063-6394a90a2b48
Route
TOPICAL
Published
Effective Date 2025-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (7.34 g)
Inactive Ingredients
Water Triethoxycaprylylsilane Hydroxyacetophenone Ceramide Np Ceramide Ns Phenyl Trimethicone Dipropylene Glycol Butylene Glycol Allantoin Disteardimonium Hectorite Phytosphingosine Titanium Dioxide 1,2-hexanediol Neopentyl Glycol Diheptanoate Ceramide 9 Tin Oxide Aloe Barbadensis Leaf C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Propanediol Zeolite A Glyceryl Glucoside Glycerin Panthenol Caprylhydroxamic Acid Dibutyl Adipate Cholesterol Hyaluronic Acid Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Peg-10 Dimethicone (300 Cst) C13-14 Isoparaffin Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Cetearyl Alcohol Stearic Acid Butyloctyl Salicylate Silica Caprylyl Methicone Bakuchiol Magnesium Sulfate Benzotriazolyl Dodecyl P-cresol C15-23 Alkane Hydrogenated Soybean Lecithin Tocopherol Caprylyl Glycol Ethylhexyl Methoxycrylene Ceramide Ap Calcium Aluminum Borosilicate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-17

Description

Zink Oxide 14.68%


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.

■ 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:

■ Children under 6 months of age: Ask a doctor.

■ Reapply at least every 2 hours.

■ Use a water-resistant sunscreen if swimming or sweating

■ Limit time in the sun, especially from 10 a.m. - 2 p.m.

■ Wear long-sleeved shirts, pants, hats, and sunglasses

Description

Zink Oxide 14.68%

Section 50565-1

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

Section 50566-9

stop use and ask a doctor if ■ rash occurs.

Section 50567-7

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

Section 50570-1

■ on damaged skin or broken skin

Section 51727-6

Water

Dimethicone

Butyloctyl Salicylate

Propanediol

Ethylhexyl Methoxycrylene

PEG-10 Dimethicone

Phenyl Trimethicone

Silica

Zeolite

Caprylyl Methicone

Glyceryl Glucoside

Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone

Glycerin

Magnesium Sulfate

Dimethicone/Vinyl Dimethicone Crosspolymer

Panthenol

Calcium Aluminum Borosilicate

Aloe Barbadensis Leaf Extract

Dipropylene Glycol

Benzotriazolyl Dodecyl p-Cresol

Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

Triethoxycaprylylsilane

C30-45 Alkyl Cetearyl Dimethicone Crosspolymer

Disteardimonium Hectorite

Hydroxyacetophenone

Allantoin

Caprylyl Glycol

Caprylhydroxamic Acid

Titanium Dioxide

Butylene Glycol

Tin Oxide

1,2-Hexanediol

Dibutyl Adipate

Neopentyl Glycol Diheptanoate

C15-23 Alkane

Hydrogenated Lecithin

Cetearyl Alcohol

Stearic Acid

C13-14 Alkane

Bakuchiol

Camellia Sinensis Leaf Extract

Hyaluronic Acid

Pentasodium Tetracarboxymethyl Heptadecanoyl Dipeptide-12

Tocopherol

Ceramide NP

Ceramide NS

Cholesterol

Phytosphingosine

Ceramide AP

Ceramide AS

Ceramide EOP

Section 51945-4

Section 55106-9

Zink Oxide 14.68%

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.

Sunscreen

Sunscreen


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.

■ 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:

■ Children under 6 months of age: Ask a doctor.

■ Reapply at least every 2 hours.

■ Use a water-resistant sunscreen if swimming or sweating

■ 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)

stop use 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)

■ on damaged skin or broken skin

Section 51727-6 (51727-6)

Water

Dimethicone

Butyloctyl Salicylate

Propanediol

Ethylhexyl Methoxycrylene

PEG-10 Dimethicone

Phenyl Trimethicone

Silica

Zeolite

Caprylyl Methicone

Glyceryl Glucoside

Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone

Glycerin

Magnesium Sulfate

Dimethicone/Vinyl Dimethicone Crosspolymer

Panthenol

Calcium Aluminum Borosilicate

Aloe Barbadensis Leaf Extract

Dipropylene Glycol

Benzotriazolyl Dodecyl p-Cresol

Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

Triethoxycaprylylsilane

C30-45 Alkyl Cetearyl Dimethicone Crosspolymer

Disteardimonium Hectorite

Hydroxyacetophenone

Allantoin

Caprylyl Glycol

Caprylhydroxamic Acid

Titanium Dioxide

Butylene Glycol

Tin Oxide

1,2-Hexanediol

Dibutyl Adipate

Neopentyl Glycol Diheptanoate

C15-23 Alkane

Hydrogenated Lecithin

Cetearyl Alcohol

Stearic Acid

C13-14 Alkane

Bakuchiol

Camellia Sinensis Leaf Extract

Hyaluronic Acid

Pentasodium Tetracarboxymethyl Heptadecanoyl Dipeptide-12

Tocopherol

Ceramide NP

Ceramide NS

Cholesterol

Phytosphingosine

Ceramide AP

Ceramide AS

Ceramide EOP

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Zink Oxide 14.68%

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.

Sunscreen

Sunscreen


Advanced Ingredient Data


Raw Label Data

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