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

Purpose

Sunscreen

Description

Zinc Oxide 17% w/v


Medication Information

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

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.

Purpose

Sunscreen

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

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

Description

Zinc Oxide 17% w/v

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.

Packaging

Drug Facts

Active Ingredient

Zinc Oxide 17% w/v


Structured Label Content

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

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.

Purpose

Sunscreen

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

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

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.

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Zinc Oxide 17% w/v


Advanced Ingredient Data


Raw Label Data

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