SPF 50 SUNSCREEN STICK- zinc oxide stick

SPF 50 Sunscreen Stick by

Drug Labeling and Warnings

SPF 50 Sunscreen Stick by is a Otc medication manufactured, distributed, or labeled by OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide….20.0%

Purpose

Sunscreen

Keep Out of Reach of Children

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

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.

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 this risk regularly use a sunscreen with 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-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

Aloe Extract, Behenyl Behenate, Shea Butter, Caprylic/Capric Triglyceride, Coconut Oil, Candelilla Wax, Sunflower Oil, Sunflower Wax, Polyhydroxystearic Acid, Castor Oil, Jojoba Oil, Squalane, Cocoa Butter, Tocopherol (Vitamin E).

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SPF 50 SUNSCREEN STICK 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-178
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)	395 mg  in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	162 mg  in 1 g
COCOA BUTTER (UNII: 512OYT1CRR)	57 mg  in 1 g
SUNFLOWER OIL (UNII: 3W1JG795YI)	64 mg  in 1 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63645-178-05	14 g in 1 CONTAINER; Type 0: Not a Combination Product	02/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/24/2020

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(63645-178) , LABEL(63645-178)