drmtlgy​® 

drmtlgy​® 
SPL v2
SPL
SPL Set ID 483d0d28-56f3-4b37-af03-0331e1653d73
Route
topical
Published
Effective Date 2025-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (10 g) titanium dioxide (5.5 g)
Inactive Ingredients
water cyclomethicone 5 caprylyl trisiloxane alkyl (c12-15) benzoate glycerin lauryl peg-9 polydimethylsiloxyethyl dimethicone octyldodecyl neopentanoate dimethicone, unspecified aluminum oxide sodium chloride hyaluronate sodium tocopherol ascorbyl palmitate polyhydroxystearic acid (2300 mw) methicone (20 cst) disteardimonium hectorite triethoxysilylethyl polydimethylsiloxyethyl hexyl dimethicone polyglyceryl-3 polydimethylsiloxyethyl dimethicone (4000 mpa.s) dimethicone/peg-10/15 crosspolymer triethoxycaprylylsilane propylene carbonate 1,2-hexanediol caprylyl glycol ethylhexylglycerin phenoxyethanol ferric oxide yellow ferric oxide red ferrosoferric oxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-08

Purpose

Sunscreen

Description

Zinc Oxide 10% Titanium Dioxide 5.5%


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 10% Titanium Dioxide 5.5%

Section 42229-5

PROTECT

Broad Spectrum

UVA/UVB Protection

Water Resistant for up to 80 minutes

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.

​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.

Packaging

​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.

​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 after 80 minutes of swimming or sweating. Reapply immediately after towel drying 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 10%

Titanium Dioxide 5.5%

Questions Or Comments?

1-888-DRMTLGY

​​inactive Ingredients

Water/Aqua/Eau, Cyclopentasiloxane, Caprylyl Methicone, C12-15 Alkyl Benzoate, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Octyldodecyl Neopentanoate, Dimethicone, Alumina, Sodium Chloride, Sodium Hyaluronate, Tocopherol, Ascorbyl Palmitate, Polyhydroxystearic Acid, Methicone, Disteardimonium Hectorite, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Triethoxycaprylylsilane, Propylene Carbonate, 1,2 Hexanediol, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)


Structured Label Content

Section 42229-5 (42229-5)

PROTECT

Broad Spectrum

UVA/UVB Protection

Water Resistant for up to 80 minutes

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.

​uses (​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.

Packaging

​purpose (​Purpose)

Sunscreen

​warnings (​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.

​directions (​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 after 80 minutes of swimming or sweating. Reapply immediately after towel drying at least every 2 hours.

​drug Facts (​Drug Facts)

​precautions (​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 10%

Titanium Dioxide 5.5%

Questions Or Comments? (Questions or comments?)

1-888-DRMTLGY

​​inactive Ingredients (​​Inactive Ingredients)

Water/Aqua/Eau, Cyclopentasiloxane, Caprylyl Methicone, C12-15 Alkyl Benzoate, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Octyldodecyl Neopentanoate, Dimethicone, Alumina, Sodium Chloride, Sodium Hyaluronate, Tocopherol, Ascorbyl Palmitate, Polyhydroxystearic Acid, Methicone, Disteardimonium Hectorite, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Triethoxycaprylylsilane, Propylene Carbonate, 1,2 Hexanediol, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)


Advanced Ingredient Data


Raw Label Data

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