ZINKA SPF 50 FACESTICK- homosalate, octinoxate, octisalate, octocrylene, zinc oxide stick

Zinka SPF 50 Facestick by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Homosalate (6.9%), Octinoxate (4.7%), Octisalate (4.0%), Octocrylene (3.4%), Zinc Oxide (5.0%)

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.

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts. Keep out of eyes. Rinse with water to remove.

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.

Inactive Ingredients

BHT, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Flavor Methylparaben, Microcrystalline Wax, Ozokerite, Polyethylene, Propylparaben, PVP/Hexadecene Copolymer, Synthetic Beeswax, Tapioca Starch Polymethylsilsesquioxane, Tocopherol,.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ZINKA SPF 50 FACESTICK 
homosalate, octinoxate, octisalate, octocrylene, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52993-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.7 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.90 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	10.50 mg  in 1 g
CERESIN (UNII: Q1LS2UJO3A)	10.30 mg  in 1 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	15.5 mg  in 1 g
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)	13 mg  in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	6.3 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: 52993-150-03	1 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/09/2014

Labeler - Zinka (153569595)

Registrant - Zinka (153569595)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(52993-150) , LABEL(52993-150)