Dermatone Mineral Spf 30 Sunscreen Lotion

Dermatone Mineral Spf 30 Sunscreen Lotion
SPL v3
SPL
SPL Set ID 26e3209f-cb5c-484e-9b2e-74dc397d4790
Route
TOPICAL
Published
Effective Date 2025-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20 g)
Inactive Ingredients
Caprylic/capric Triglyceride Coco-caprylate Butyloctyl Salicylate Niacinamide Polyhydroxystearic Acid (2300 Mw) Glycerin Panthenol .alpha.-tocopherol Acetate Sucrose Palmitate Glyceryl Stearate Xanthan Gum Citric Acid Saccharide Isomerate Water Sucrose Tristearate Sodium Stearoyl Glutamate Benzyl Alcohol Dehydroacetic Acid Sodium Phytate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-21

Description

Zinc Oxide 20%                        Sunscreen

Purpose

Zinc Oxide 20%                        Sunscreen


Medication Information

Warnings and Precautions

WARNINGS

For external use only.

When using this product:

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

Indications and Usage

Uses

• Helps prevent sunburn, higher SPF gives more sunburn protection

• 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

Purpose

Zinc Oxide 20%                        Sunscreen

Dosage and Administration

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.

• Reapply at least every 2 hours

٠apply to all areas of the skin exposed to the sun.

٠Reapply as needed or after towel drying, swimming, or sweating.

Sun Protection Measures. Spending tme 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from

10 a.m. - 2. p.m. • wear a long-sleeve shirt, pants, hats, and sunglasses.

• children under 6 months: Ask a doctor.

Description

Zinc Oxide 20%                        Sunscreen

Section 51945-4

Inactive Ingredeints

WATER

CAPRYLIC/CAPRIC TRIGLYCERIDE

COCO-CAPRYLATE

BUTYLOCTYL SALICYLATE

NIACINAMIDE

POLYHYDROXYSTEARIC ACID

GLYCERIN

PANTHENOL

.ALPHA.-TOCOPHEROL ACETATE

SUCROSE PALMITATE

XANTHAN GUM

CITRIC ACID

SACCHARIDE ISOMERATE

SUCROSE TRISTEARATE

SODIUM STEAROYL GLUTAMATE

BENZYL ALCOHOL

DEHYDROACETIC ACID

SODIUM PHYTATE

Active Ingredients                 purpose

Zinc Oxide 20%                        Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Uses

• Helps prevent sunburn, higher SPF gives more sunburn protection

• 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)

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.

• Reapply at least every 2 hours

٠apply to all areas of the skin exposed to the sun.

٠Reapply as needed or after towel drying, swimming, or sweating.

Sun Protection Measures. Spending tme 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from

10 a.m. - 2. p.m. • wear a long-sleeve shirt, pants, hats, and sunglasses.

• children under 6 months: Ask a doctor.

Warnings and Precautions (34071-1)

WARNINGS

For external use only.

When using this product:

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

Section 51945-4 (51945-4)

Inactive Ingredeints

WATER

CAPRYLIC/CAPRIC TRIGLYCERIDE

COCO-CAPRYLATE

BUTYLOCTYL SALICYLATE

NIACINAMIDE

POLYHYDROXYSTEARIC ACID

GLYCERIN

PANTHENOL

.ALPHA.-TOCOPHEROL ACETATE

SUCROSE PALMITATE

XANTHAN GUM

CITRIC ACID

SACCHARIDE ISOMERATE

SUCROSE TRISTEARATE

SODIUM STEAROYL GLUTAMATE

BENZYL ALCOHOL

DEHYDROACETIC ACID

SODIUM PHYTATE

Active Ingredients                 purpose (Active ingredients                 Purpose)

Zinc Oxide 20%                        Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)