31188175-a4ca-449f-e063-6394a90a3c05

SPL v2
SPL
SPL Set ID 31188175-a4ca-449f-e063-6394a90a3c05
Route
topical
Published
Effective Date 2020-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (80 mg) zinc oxide (38 mg)
Inactive Ingredients
alumina dimethicone dimethicone crosspolymer ci 77491 lauryl peg/ppg-18/18 methicone hydrogen dimethicone (20 cst) tetrahexyldecyl ascorbate cyclohexasiloxane dimethicone/vinyl dimethicone crosspolymer (soft particle) dimethiconol (2000 cst) ci 77499 ci 77492 peg-10 dimethicone (600 cst) cyclopentasiloxane alpha-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-05-18

Purpose

Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Section 51727-6

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

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:

Titanium Dioxide 8% Zinc Oxide 3.8%


Structured Label Content

Section 51727-6 (51727-6)

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

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:

Titanium Dioxide 8% Zinc Oxide 3.8%


Advanced Ingredient Data


Raw Label Data

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