SPL v2
SPL
SPL Set ID 33119ec6-2cd8-8978-e063-6394a90afd97
Route
TOPICAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Polyhydroxystearic Acid (2300 Mw) Prunus Amygdalus Dulcis (sweet Almond) Oil Beeswax Hydrolyzed Jojoba Esters .alpha.-tocopherol Acetate Lemon Balm Oil Sorbitan Olivate Calendula Officinalis Flower Mica Plantago Lanceolata Leaf Silica Sunflower Oil Squalane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Zinc Oxide 20%


Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

Indications and Usage

Helps prevent sunburn.

Dosage and Administration

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

For children under 6 months of age: ask a doctor.

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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses.

Description

Zinc Oxide 20%

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Ceenter immediately.

Section 51727-6

Cera Alba (Beeswax), Extracts of Calendula Officinalis (Marigold) Flower*, Melissa Officinalis (Lemon Balm) Leaf* and Pantago Lanceolata (Plantain) Leaf in Healianthus Annuus (Sunflower) Seed Oil, Jojoba Esters, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalan (Plant-Based) *Certified Organic Ingredients.

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 20%

Hiya Kids Mineral Sunscreen Package Label


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

For children under 6 months of age: ask a doctor.

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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses.

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Ceenter immediately.

Section 51727-6 (51727-6)

Cera Alba (Beeswax), Extracts of Calendula Officinalis (Marigold) Flower*, Melissa Officinalis (Lemon Balm) Leaf* and Pantago Lanceolata (Plantain) Leaf in Healianthus Annuus (Sunflower) Seed Oil, Jojoba Esters, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalan (Plant-Based) *Certified Organic Ingredients.

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 20%

Hiya Kids Mineral Sunscreen Package Label


Advanced Ingredient Data


Raw Label Data

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