SPL v1
SPL
SPL Set ID 2cc73c4f-30ea-0a51-e063-6394a90ac9a4
Route
TOPICAL
Published
Effective Date 2019-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (160 mg)
Inactive Ingredients
Polyhydroxystearic Acid (2300 Mw) Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Dimethicone Crosspolymer Iron Oxides Tetrahexyldecyl Ascorbate Ceramide 3 Peg-10 Dimethicone (600 Cst) Caprylic/capric Triglyceride Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Cyclopentasiloxane Cyclohexasiloxane Alpha-tocopherol Acetate Dimethiconol (2000 Cst) Hydrogen Dimethicone (20 Cst)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-23

Description

Zinc Oxide 16%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 16%

Section 51727-6

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Section 51945-4

Warning:

For external use only.

(purpose)

Sunscreen

Directions:

Apply liberally 15 minutes before sun exposure.

Actve Ingredient:

Zinc Oxide 16%

Warning and Directions:

For external use only. Aplly liberally 15 minutes before sun exposure.


Structured Label Content

Section 51727-6 (51727-6)

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Section 51945-4 (51945-4)

Warning:

For external use only.

(purpose) ((Purpose))

Sunscreen

Directions:

Apply liberally 15 minutes before sun exposure.

Actve Ingredient:

Zinc Oxide 16%

Warning and Directions: (Warning and DIrections:)

For external use only. Aplly liberally 15 minutes before sun exposure.


Advanced Ingredient Data


Raw Label Data

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