30dfa973-3217-1e18-e063-6294a90a8d41

SPL v2
SPL
SPL Set ID 30dfa973-3217-1e18-e063-6294a90a8d41
Route
topical
Published
Effective Date 2022-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (160 mg)
Inactive Ingredients
dimethicone/vinyl dimethicone crosspolymer (soft particle) ci 77499 cyclohexasiloxane peg-10 dimethicone (600 cst) caprylic/capric triglyceride hydrogen dimethicone (20 cst) polyhydroxystearic acid (2300 mw) cyclopentasiloxane dimethiconol (2000 cst) ci 77492 ci 77491 tetrahexyldecyl ascorbate ceramide 3 dimethicone crosspolymer dimethicone alpha-tocopherol acetate vinyl dimethicone/methicone silsesquioxane crosspolymer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-09-13

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

Directions:

Apply liberally 15 minutes before 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

Directions:

Apply liberally 15 minutes before sun exposure

Active Ingredients:

Zinc Oxide 16%


Advanced Ingredient Data


Raw Label Data

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