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

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose

Sunscreen


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

All Sections (JSON)