SPL v2
SPL
SPL Set ID 300268ff-f9ef-1006-e063-6294a90a5fdf
Route
TOPICAL
Published
Effective Date 2022-11-23
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/vinyl Dimethicone Crosspolymer (soft Particle) Cyclohexasiloxane Dimethicone Crosspolymer Ci 77491 Cyclopentasiloxane Lauryl Peg/ppg-18/18 Methicone Dimethiconol (2000 Cst) Peg-10 Dimethicone (600 Cst) Dimethicone Hydrogen Dimethicone (20 Cst) Alpha-tocopherol Acetate Tetrahexyldecyl Ascorbate

Identifiers & Packaging

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

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
  • Keep out of reach of children
Warnings:
  • For external use only
  • Keep out of reach of children
Directions:

Apply liberally 15 minute 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
  • Keep out of reach of children
Warnings:
  • For external use only
  • Keep out of reach of children
Directions:

Apply liberally 15 minute before sun exposure

Active Ingredients:

Titanium Dioxide 8% Zinc Oxide 3.8%


Advanced Ingredient Data


Raw Label Data

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