2fb00db0-4c37-56c6-e063-6294a90a8aff

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

Purpose

Sunscreen

Description

Zinc Oxide 16%


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

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