SPL v1
SPL
SPL Set ID 2cc84aba-006b-a78e-e063-6294a90ae040
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
Dimethicone Crosspolymer Hydrogen Dimethicone (20 Cst) Peg-10 Dimethicone (600 Cst) Polyhydroxystearic Acid (2300 Mw) Caprylic/capric Triglyceride Ceramide 3 Cyclohexasiloxane Dimethicone Tetrahexyldecyl Ascorbate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Alpha-tocopherol Acetate Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Dimethiconol (2000 Cst) Iron Oxides Cyclopentasiloxane

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.

Active Ingredient:

Zinc Oxide 16%

Warning and Directions:

For external use only. Appply 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.

Active Ingredient:

Zinc Oxide 16%

Warning and Directions:

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


Advanced Ingredient Data


Raw Label Data

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