SPL v2
SPL
SPL Set ID 2fb19ed7-8cee-ce80-e063-6394a90ad3dc
Route
TOPICAL
Published
Effective Date 2022-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (38 mg) Titanium Dioxide (80 mg)
Inactive Ingredients
Alpha-tocopherol Acetate Dimethicone Ci 77491 Hydrogen Dimethicone (20 Cst) Alumina Dimethiconol (2000 Cst) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Peg-10 Dimethicone (600 Cst) Dimethicone Crosspolymer Lauryl Peg/ppg-18/18 Methicone Cyclohexasiloxane Tetrahexyldecyl Ascorbate Cyclopentasiloxane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-05

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

Cu

Section 51945-4

Section 60561-8

SAMPLE NOT FOR RESALE

Purpose:

Sunscreen

Warning:
  • For external use only.
  • Keep out of reach of children.
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

Cu

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.
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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