SIMPLE MINERAL SUNSCREEN SPF 50- zinc oxide cream

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 25.00%

Purpose

Sunscreen

Uses.

• 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 the sun.

Warnings.

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.

Keep out of reach of children.

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

Directions.

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: Ask a doctor.
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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 the risk, regularly use a sunscreen with broad spectrum SPF 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.

Other Information.

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

Inactive Ingredients

Beeswax, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Maranta Arundinacea (Arrowroot) Powder, Olea Europaea (Olive) Fruit Oil, Propolis Extract, Tallow (Adeps Bovis)

Other Information.

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

Package Labeling:

INGREDIENTS AND APPEARANCE

SIMPLE MINERAL SUNSCREEN SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87515-973
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BEESWAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CANDELILLA WAX (UNII: WL0328HX19)
OLIVE OIL (UNII: 6UYK2W1W1E)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
BEEF TALLOW (UNII: 98HPY76U4W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87515-973-00	59 mL in 1 JAR; Type 0: Not a Combination Product	02/24/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/24/2026

Labeler - Simple Sunscreen LLC (140865611)

Registrant - Pure Source, LLC (080354456)