Drmtlgy®

Drmtlgy®
SPL v1
SPL
SPL Set ID 0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8
Route
TOPICAL
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (12 g) Octinoxate (7.5 g)
Inactive Ingredients
Water Cyclomethicone 5 Niacinamide Oleth-3 Phosphate Octyldodecyl Neopentanoate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Polyisobutylene (1000 Mw) Peg-7 Trimethylolpropane Coconut Ether Glycerin .alpha.-tocopherol Acetate Polygonum Aviculare Top Hyaluronate Sodium Edetate Disodium Sodium Hydroxide Citric Acid Monohydrate Phenoxyethanol Ethylhexylglycerin Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Zinc Oxide 12% Octinoxate 7.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 12% Octinoxate 7.5%

Uses

Helps prevent sunburn. • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Section 42229-5

MEDICAL GRADE SKIN CARE

PROTECT

defend//prevent

Broad Spectrum

UVA/UVB Protection

Dist. by DRMTLGY, LLC

Chatsworth, CA 91311

www.DRMTLGY.com

Made in USA

Section 50565-1

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

Warnings

For external use only.

When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs.

Packaging

Directions

• Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours. 

Drug Facts

Precautions

• 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 value of SPF 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. Children under 6 months of age: Ask a physician.

Active Ingredients

Zinc Oxide 12%

Octinoxate 7.5%

Inactive Ingredients:

Water, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Glycerin, Tocopheryl Acetate, Polygonum Aviculare Extract, Sodium Hyaluronate, Disodium EDTA, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane

Questions Or Comments? 

1-888-DRMTLGY


Structured Label Content

Uses

Helps prevent sunburn. • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Section 42229-5 (42229-5)

MEDICAL GRADE SKIN CARE

PROTECT

defend//prevent

Broad Spectrum

UVA/UVB Protection

Dist. by DRMTLGY, LLC

Chatsworth, CA 91311

www.DRMTLGY.com

Made in USA

Section 50565-1 (50565-1)

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

Purpose

Sunscreen

Warnings

For external use only.

When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs.

Packaging

Directions

• Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours. 

Drug Facts

Precautions

• 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 value of SPF 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. Children under 6 months of age: Ask a physician.

Active Ingredients (Active ingredients)

Zinc Oxide 12%

Octinoxate 7.5%

Inactive Ingredients:

Water, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Glycerin, Tocopheryl Acetate, Polygonum Aviculare Extract, Sodium Hyaluronate, Disodium EDTA, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane

Questions Or Comments?  (Questions or comments? )

1-888-DRMTLGY


Advanced Ingredient Data


Raw Label Data

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