ETHICAL ZINC NATURAL CLEAR ZINC SUNSCREEN SPF-50- zinc oxide lotion
ETHICAL ZINC PTY LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ETHICAL ZINC - NATURAL CLEAR ZINC SUNSCREEN SPF-50 (72962-101)

ACTIVE INGREDIENTS

ZINC OXIDE 22.00%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN.
IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DECREASES THE RISK OF 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
CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

INACTIVE INGREDIENTS

MEDIUM CHAIN TRIGLYCERIDES, WHITE BEESWAX, COCO-CAPRYLATE, CASTOR OIL, COCONUT OIL, POLYGLYCERYL-3 POLYRICINOLEATE, ISOSTEARIC ACID, D-ALPHA-TOCOPHERYL ACETATE, FRENCH VANILLA FRAGRANCE

OTHER INFORMATION

PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

USA_40x134mmx100g_FINAL_OUTLINE

ETHICAL ZINC NATURAL CLEAR ZINC SUNSCREEN SPF-50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72962-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	22 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WHITE WAX (UNII: 7G1J5DA97F)
COCO-CAPRYLATE (UNII: 4828G836N6)
CASTOR OIL (UNII: D5340Y2I9G)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
ISOSTEARIC ACID (UNII: X33R8U0062)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72962-101-11	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/11/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/29/2017

Labeler - ETHICAL ZINC PTY LTD (745184258)