Drmtlgy®

Drmtlgy®
SPL v3
SPL
SPL Set ID bd0981cb-49ce-4eaf-bd9e-db48f56b7314
Route
TOPICAL
Published
Effective Date 2023-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (17 g)
Inactive Ingredients
Water Isododecane Propanediol Dimethicone, Unspecified Medium-chain Triglycerides Polyglyceryl-6 Polyricinoleate Polymethylsilsesquioxane/trimethylsiloxysilicate Butyloctyl Salicylate Alkyl (c12-15) Benzoate Cocoyl Caprylocaprate Polyglyceryl-10 Dioleate Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Polyhydroxystearic Acid (2300 Mw) Phenylsilanetriol Soybean Lecithin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Saccharum Officinarum Stem Fructooligosaccharides Platelet Glycoprotein Vi Citrus Bioflavonoids Guar Gum Glycerin Shea Butter 1,2-hexanediol C18-36 Acid Triglyceride Tribehenin Disteardimonium Hectorite Propylene Carbonate Aminomethylpropanol Caprylhydroxamic Acid Polysorbate 20 Pentylene Glycol Decyl Glucoside Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-21

Description

Zinc Oxide 17% w/v

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 17% w/v

Uses

• 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.

Section 42229-5

MEDICAL GRADE SKIN CARE

UVA/UVB Protection

100% Mineral Filters

Water & Sweat Resistant (80 Minutes)

Oil-Free

Vegan

Paraben Free

Sulfate Free

Gluten Free

Fragrance Free

Never Tested On Animals

Made in USA with globally sourced components.

Distributed by: DRMTLGY, LLC

Canoga Park, CA 91304

www.DRMTLGY.com

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

Do not use • on damaged or broken skin

When using this product • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if • rash occurs

Packaging

Directions

• apply generously to face and neck avoiding eye area 15 minutes before sun exposure.

• reapply:

  • after 80 minutes of swimming or sweating

     immediately after towel drying

  • at least every 2 hours

Sun Protection Measures. 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 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

• children under 6 months of age: Ask a doctor

Drug Facts

Active Ingredient

Zinc Oxide 17% w/v

Other Information

• protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, Isododecane, Propanediol, Dimethicone, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Coco-Caprylate/Caprate, Polyglyceryl-10 Dioleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyhydroxystearic Acid, Polyphenylsilsesquioxane, Lecithin, Polysilicone-11, Fructooligosaccharide, Glycoproteins, Bioflavonoids, Cyamopsis Tetragonoloba (Guar) Gum, Glycerin, Butyrospermum Parkii (Shea) Butter, 1,2-Hexanediol, C18-36 Acid Triglyceride, Tribehenin, Disteardimonium Hectorite, Propylene Carbonate, Aminomethyl Propanol, Caprylhydroxamic Acid, Polysorbate 20, Pentylene Glycol, Decyl Glucoside, Xanthan Gum


Structured Label Content

Uses

• 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.

Section 42229-5 (42229-5)

MEDICAL GRADE SKIN CARE

UVA/UVB Protection

100% Mineral Filters

Water & Sweat Resistant (80 Minutes)

Oil-Free

Vegan

Paraben Free

Sulfate Free

Gluten Free

Fragrance Free

Never Tested On Animals

Made in USA with globally sourced components.

Distributed by: DRMTLGY, LLC

Canoga Park, CA 91304

www.DRMTLGY.com

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

Do not use • on damaged or broken skin

When using this product • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if • rash occurs

Packaging

Directions

• apply generously to face and neck avoiding eye area 15 minutes before sun exposure.

• reapply:

  • after 80 minutes of swimming or sweating

     immediately after towel drying

  • at least every 2 hours

Sun Protection Measures. 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 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

• children under 6 months of age: Ask a doctor

Drug Facts

Active Ingredient (Active ingredient)

Zinc Oxide 17% w/v

Other Information (Other information)

• protect the product in this container from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Isododecane, Propanediol, Dimethicone, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Coco-Caprylate/Caprate, Polyglyceryl-10 Dioleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyhydroxystearic Acid, Polyphenylsilsesquioxane, Lecithin, Polysilicone-11, Fructooligosaccharide, Glycoproteins, Bioflavonoids, Cyamopsis Tetragonoloba (Guar) Gum, Glycerin, Butyrospermum Parkii (Shea) Butter, 1,2-Hexanediol, C18-36 Acid Triglyceride, Tribehenin, Disteardimonium Hectorite, Propylene Carbonate, Aminomethyl Propanol, Caprylhydroxamic Acid, Polysorbate 20, Pentylene Glycol, Decyl Glucoside, Xanthan Gum


Advanced Ingredient Data


Raw Label Data

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