SPL v1
SPL
SPL Set ID 44952d01-7f38-0a9c-e063-6394a90a2018
Route
TOPICAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (5.74 g) Titanium Dioxide (5.1359 g)
Inactive Ingredients
Propanediol Niacinamide Hydrogenated Soybean Lecithin Alumina Silica Caprylhydroxamic Acid Caprylic/capric Triglyceride Pentylene Glycol Butyrospermum Parkii (shea) Butter Glycerin Sodium Hydroxide Water Jojoba Oil, Randomized 1,2-hexanediol Alpha-tocopherol Acetate Butyloctyl Salicylate Squalane Phenoxyethanol Polyhydroxystearic Acid (2300 Mw) Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Stearic Acid Carthamus Tinctorius (safflower) Seed Oil Allantoin Xanthan Gum Soybean Oil Sodium Hyaluronate Tocopherol Glycogen Ethylhexylglycerin Sorbitan Isostearate Citric Acid

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01
Description

Titanium Dioxide 5.14% Zinc Oxide 5.74%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin aging caused by exposure to the sun.

Dosage and Administration

  • Shake well before use.
  • Apply generously to face and neck 15 minutes before sun exposure.
  • Use water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeved shirts, pants, hats, and sunglasses.

  • Children under 6 months of age: Ask a doctor.
Description

Titanium Dioxide 5.14% Zinc Oxide 5.74%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, PENTYLENE GLYCOL, GLYCERIN, SQUALANE, SILICA, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALUMINA, HYDROGENATED LECITHIN, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PROPANEDIOL, STEARIC ACID, NIACINAMIDE, JOJOBA ESTERS, 1,2-HEXANEDIOL, ALLANTOIN, TOCOPHERYL ACETATE, XANTHAN GUM, GLYCINE SOJA (SOYBEAN) OIL, SODIUM HYALURONATE, TOCOPHEROL, GLYCOGEN, ETHYLHEXYLGLYCERIN, CAPRYLHYDROXAMIC ACID, SORBITAN ISOSTEARATE, CITRIC ACID, SODIUM HYDROXIDE

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 5.14%

Zinc Oxide 5.74%

Section 60561-8

Protect the product in this container from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin aging caused by exposure to the sun.

Dosage and Administration (34068-7)

  • Shake well before use.
  • Apply generously to face and neck 15 minutes before sun exposure.
  • Use water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeved shirts, pants, hats, and sunglasses.

  • Children under 6 months of age: Ask a doctor.
Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, PENTYLENE GLYCOL, GLYCERIN, SQUALANE, SILICA, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALUMINA, HYDROGENATED LECITHIN, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PROPANEDIOL, STEARIC ACID, NIACINAMIDE, JOJOBA ESTERS, 1,2-HEXANEDIOL, ALLANTOIN, TOCOPHERYL ACETATE, XANTHAN GUM, GLYCINE SOJA (SOYBEAN) OIL, SODIUM HYALURONATE, TOCOPHEROL, GLYCOGEN, ETHYLHEXYLGLYCERIN, CAPRYLHYDROXAMIC ACID, SORBITAN ISOSTEARATE, CITRIC ACID, SODIUM HYDROXIDE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 5.14%

Zinc Oxide 5.74%

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:00.446372 · Updated: 2026-03-14T23:12:06.957806