SPL v2
SPL
SPL Set ID 2fb00db0-4c37-56c6-e063-6294a90a8aff
Route
TOPICAL
Published
Effective Date 2024-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (160 mg)
Inactive Ingredients
Peg-10 Dimethicone (600 Cst) Polyhydroxystearic Acid (2300 Mw) Hydrogen Dimethicone (20 Cst) Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Cyclopentasiloxane Caprylic/capric Triglyceride Ceramide 3 Cyclohexasiloxane Dimethicone Crosspolymer Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Alpha-tocopherol Acetate Dimethiconol (2000 Cst) Tetrahexyldecyl Ascorbate Ci 77499 Ci 77491 Ci 77492

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-09

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

Section 60561-8

SAMPLE NOT FOR RESALE

Purpose:

Sunscreen

Warning:

For external use only. Keep out of the reach of children.

Directions:

Apply liberally 15 minutes before sun exposure.

Active Ingredient:

Zinc Oxide 16%


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)

Section 60561-8 (60561-8)

SAMPLE NOT FOR RESALE

Purpose:

Sunscreen

Warning:

For external use only. Keep out of the reach of children.

Directions:

Apply liberally 15 minutes before sun exposure.

Active Ingredient:

Zinc Oxide 16%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)