SPF 50 SUNSCREEN- zinc oxide stick

SPF 50 Sunscreen by

Drug Labeling and Warnings

SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Salt and Stone LLC, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Non-Nano Zinc Oxide 22.5%

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 occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a poison control center right away.

Directions

Apply liberally 15 minutes before sun exposure
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 a broad spectrum SPF of 15 or higher & other sun protection measures including:
Limit time in the sun, especially from 10am - 2pm.
Wear long-sleeve shirts, pants, hats, and sunglasses.
Children under 6 months: Ask a doctor

Other Information

Protect this product from excess heat and direct sun.

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Cera Alba (Beeswax)*,Butyrospermum Parkii (Shea) Butter*, Silica, Copernicia Cerifera (Carnauba) Wax*, Theobroma Cacao (Cocoa) Seed Butter*, Mica, Simmondsia Chinensis (Jojoba) Seed Oil*, Tocopherol (Vitamin E), Iron Oxides. *Organic

Package Labeling:

INGREDIENTS AND APPEARANCE

SPF 50 SUNSCREEN 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	225 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCONUT OIL (UNII: Q9L0O73W7L)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
COCOA BUTTER (UNII: 512OYT1CRR)
MICA (UNII: V8A1AW0880)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-115-00	15 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2019

Labeler - Salt and Stone LLC (080683697)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(71585-115)