SPL v2
SPL
SPL Set ID 47aa8605-e536-b998-e063-6394a90ad9f0
Route
TOPICAL
Published
Effective Date 2026-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4 g) Zinc Oxide (19.5 g)
Inactive Ingredients
Pentylene Glycol Medium-chain Triglycerides Jojoba Oil, Randomized Sodium Chloride Fragrance 13576 Caprylyl Glycol Cetyl Diglyceryl Tris(trimethylsiloxy)silylethyl Dimethicone (3500 Mm2/s) Ethylhexylglycerin Hydrogenated Polydecene Type I Silicon Dioxide Stearic Acid Water Sorbitan Olivate Synthetic Beeswax Polyhydroxystearic Acid Stearate Glycerin 2,3,5,6-tetrafluorophenol Propanediol Dimethicone Hydrogen Dimethicone (13 Cst) Phytate Sodium Isopropyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-05

Description

Active Ingredient Zinc Oxide Titanium Dioxide


Medication Information

Warnings and Precautions

WARNINGS

For external use only

Do not use on damaged or broken skin

when using this product keep out of eyes-rinse with water to remove.

Indications and Usage

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun protection measures, decreases the reisk of skin cancer and early skim agingcaused by the s

Dosage and Administration

Apply liberally 15 minutews befor sun exposure

Reaaply:

- after 80 monutes of swimming or sweating

- immediatly after towel drying

- at least every 2 hours

Description

Active Ingredient Zinc Oxide Titanium Dioxide

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 51727-6

Caprylic/Capric Triglyceride

Caprylyl Glycol

Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone

Dimethicone

Dimethicone/Methicone Copolymer

Sodium Phytate

Ethylhexylglycerin

Glycerin

Hydrogenated Polydecene

Isopropyl Myristate

Jojoba Esters

Pentylene Glycol

Polyhydroxystearic Acid

Propanediol

Silica

Sodium Chloride

Sorbitan Olivate

Stearic Acid

Synthetic Beeswax

Tetrafluoropropene

Fragrance

Water

Section 51945-4

Section 55105-1

Zinc Oxide - 19.5% ................. Sunscreen

Titanium Dioxide – 4.0%.................. Sunscreen

Section 55106-9

Active Ingredient

Zinc Oxide

Titanium Dioxide


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun protection measures, decreases the reisk of skin cancer and early skim agingcaused by the s

Dosage and Administration (34068-7)

Apply liberally 15 minutews befor sun exposure

Reaaply:

- after 80 monutes of swimming or sweating

- immediatly after towel drying

- at least every 2 hours

Warnings and Precautions (34071-1)

WARNINGS

For external use only

Do not use on damaged or broken skin

when using this product keep out of eyes-rinse with water to remove.

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 51727-6 (51727-6)

Caprylic/Capric Triglyceride

Caprylyl Glycol

Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone

Dimethicone

Dimethicone/Methicone Copolymer

Sodium Phytate

Ethylhexylglycerin

Glycerin

Hydrogenated Polydecene

Isopropyl Myristate

Jojoba Esters

Pentylene Glycol

Polyhydroxystearic Acid

Propanediol

Silica

Sodium Chloride

Sorbitan Olivate

Stearic Acid

Synthetic Beeswax

Tetrafluoropropene

Fragrance

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Zinc Oxide - 19.5% ................. Sunscreen

Titanium Dioxide – 4.0%.................. Sunscreen

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide

Titanium Dioxide


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)