SPL v1
SPL
SPL Set ID 04f0d499-26fa-1d4c-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2014-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (5.5 g)
Inactive Ingredients
Ferrosoferric Oxide Rice Bran Yellow Wax Medium-chain Triglycerides Mica Titanium Dioxide Peppermint Oil Olive Oil Calendula Officinalis Flower Echinacea Purpurea Stevia Rebaudiuna Leaf Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-3 Diisostearate .alpha.-tocopherol Acetate Triethoxycaprylylsilane Ferric Oxide Red Manganese Violet Coconut Oil Sunflower Oil Candelilla Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-16
Description

Zinc Oxide 5.5%

Medication Information

Warnings and Precautions

For external use only. Do not use on damaged skin. When using this product keep out of eyes.

Indications and Usage

Helps prevent sunburn. If uses as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure

Dosage and Administration

Cream. Apply liberally 15 minutes before sun exposure

Description

Zinc Oxide 5.5%

Section 50565-1

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

Section 51727-6

Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Beeswax, Caprylic/Capric Triglyceride, Mica, Titanium Dioxide, Oryza Sativa (Rice) Bran Wax, Mentha Pipperita (Peppermint) Oil (1), Olea Europaea (Olive) Fruit Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Stevia Rebaudiana Leaf/Stem Extract (1), Polyhydroxystearic Acid, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Manganese Violet.

(1)-Certified Organic Ingredients.

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 5.5%

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn. If uses as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure

Dosage and Administration (34068-7)

Cream. Apply liberally 15 minutes before sun exposure

Warnings and Precautions (34071-1)

For external use only. Do not use on damaged skin. When using this product keep out of eyes.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Beeswax, Caprylic/Capric Triglyceride, Mica, Titanium Dioxide, Oryza Sativa (Rice) Bran Wax, Mentha Pipperita (Peppermint) Oil (1), Olea Europaea (Olive) Fruit Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Stevia Rebaudiana Leaf/Stem Extract (1), Polyhydroxystearic Acid, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Manganese Violet.

(1)-Certified Organic Ingredients.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 5.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:50.534386 · Updated: 2026-03-14T22:53:51.342349