SPL v2
SPL
SPL Set ID 300303e7-ef89-7449-e063-6294a90ac811
Route
TOPICAL
Published
Effective Date 2022-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-23

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

Section 60561-8

SAMPLE NOT FOR RESALE

Purpose:

Sunscreen

Warning:
  • For external use only
  • Keepout of reach of children
Warnings:
  • For external use only
  • Keepout of reach of children
Directions:

Apply liberally 15 minutes befofre sun exposure.

Active Ingredients:

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
  • Keepout of reach of children
Warnings:
  • For external use only
  • Keepout of reach of children
Directions:

Apply liberally 15 minutes befofre sun exposure.

Active Ingredients:

Zinc Oxide 16%


Advanced Ingredient Data


Raw Label Data

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