SPL v1
SPL
SPL Set ID 2aec0621-6225-475d-b476-eb38a4885151
Route
TOPICAL
Published
Effective Date 2020-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10 g)
Inactive Ingredients
Acacia Decurrens Flower Tribehenin Jojoba Oil Candelilla Wax Linoleic Acid Isostearic Acid Succinic Acid Castor Oil Sunflower Oil Raspberry Seed Oil Carrot Seed Oil Tocopherol Green Tea Leaf Mentha Spicata Oil Vanilla Bean

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-02-14

Description

Zinc Oxide 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 10%

Uses

• Helps prevent sunburn.

Warnings
  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask doctor if skin rash occurs.
  • When using this product keep out of eyes. Rinse with water to remove. 
  • Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Directions

Apply liberally to the lips. 

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 a.m. – 2 p.m.

• Wear long-sleeved shirts, pants, hats, and sunglasses

Questions?

www.W3LLPEOPLE.com

Product Label

Active Ingredient

Zinc Oxide 10%

Other Information

Protect this product from excessive heat and direct sun. This is a water reisstant product.

Inactive Ingredients

Castor Isostearate Succinate, Acacia Decurrens/Jojoba/Sunflower Seed Wax/Polyglyceryl-Esters, Tribehenin, Oleic/Linoleic/Lonolenic

Polyglycarides, Euphorbia Cerifera (Candelila) Wax*, Simmondsia Chinensis (Jojoba) Oil*, Helianthus Annuus (Sunflower) Seed Oil*,

Rubus Idaeus (Red Raspberry) Seed Oil*, Daucus Carota Sativa (Carrot) Seed Oil*, Mixed Tocopherols, Camellia Sinensis Leaf Extract*,

Mentha Spicata (Spearmint)*, Vanilla Planifolia Fruit*. [± Iron Oxide (CI 77491, 77492, 77499), D & C Red 33 (CI 17200), D&C Red No. (CI

15850), Manganese Violet (CI 77742), Mica (CI 77019)

*ORGANIC INGREDIENTS


Structured Label Content

Uses

• Helps prevent sunburn.

Purpose

Sunscreen

Warnings
  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask doctor if skin rash occurs.
  • When using this product keep out of eyes. Rinse with water to remove. 
  • Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Directions

Apply liberally to the lips. 

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 a.m. – 2 p.m.

• Wear long-sleeved shirts, pants, hats, and sunglasses

Questions?

www.W3LLPEOPLE.com

Product Label

Active Ingredient

Zinc Oxide 10%

Other Information

Protect this product from excessive heat and direct sun. This is a water reisstant product.

Inactive Ingredients

Castor Isostearate Succinate, Acacia Decurrens/Jojoba/Sunflower Seed Wax/Polyglyceryl-Esters, Tribehenin, Oleic/Linoleic/Lonolenic

Polyglycarides, Euphorbia Cerifera (Candelila) Wax*, Simmondsia Chinensis (Jojoba) Oil*, Helianthus Annuus (Sunflower) Seed Oil*,

Rubus Idaeus (Red Raspberry) Seed Oil*, Daucus Carota Sativa (Carrot) Seed Oil*, Mixed Tocopherols, Camellia Sinensis Leaf Extract*,

Mentha Spicata (Spearmint)*, Vanilla Planifolia Fruit*. [± Iron Oxide (CI 77491, 77492, 77499), D & C Red 33 (CI 17200), D&C Red No. (CI

15850), Manganese Violet (CI 77742), Mica (CI 77019)

*ORGANIC INGREDIENTS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)