SPL v2
SPL
SPL Set ID 1c314b70-45a7-1bd1-e063-6294a90a0d6b
Route
TOPICAL
Published
Effective Date 2024-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Cetostearyl Alcohol Cetyl Palmitate Almond Oil Squalene Sunflower Oil Holy Basil Leaf Polyhydroxystearic Acid (2300 Mw) Silicon Dioxide Tocopherol Olea Europaea Leaf Sorbitan Olivate Alaria Esculenta Yellow Wax Jojoba Oil, Randomized Green Tea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-17

Description

Zinc Oxide 20%


Medication Information

Warnings and Precautions
  • 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.
  • Stop use and ask a doctor if rash or irritation develops and lasts.
Indications and Usage

Helps prevent sunscreen.

Dosage and Administration
  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
  • For children under 6 months of age; ask a doctor.
Description

Zinc Oxide 20%

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Alaria Esculenta (Wakame Seaweed) Extract*, Camellia Sinensis (Green Tea) Leaf Extract*, Cera Alba (Beeswax), Cetearyl Alcohol, Cetyl Palmitate, Helianthus Annus (Sunflower) Seed Oil, Jojoba Esters, Mixed Tocopherols (Vitamin E), Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europea (Olive) Leaf Extract*, Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalene (Plant Based)

*Certified Organic Ingredients

Section 51945-4

Section 55105-1

Sunscreen.

Section 55106-9

Zinc Oxide 20%


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunscreen.

Dosage and Administration (34068-7)
  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
  • For children under 6 months of age; ask a doctor.
Warnings and Precautions (34071-1)
  • 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.
  • Stop use and ask a doctor if rash or irritation develops and lasts.
Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Alaria Esculenta (Wakame Seaweed) Extract*, Camellia Sinensis (Green Tea) Leaf Extract*, Cera Alba (Beeswax), Cetearyl Alcohol, Cetyl Palmitate, Helianthus Annus (Sunflower) Seed Oil, Jojoba Esters, Mixed Tocopherols (Vitamin E), Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europea (Olive) Leaf Extract*, Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalene (Plant Based)

*Certified Organic Ingredients

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen.

Section 55106-9 (55106-9)

Zinc Oxide 20%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)