CHEM FREE SPF 30- zinc oxide cream
Owen Biosciences, Inc.

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.

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-403 Chem Free SPF 30

Active Ingredients Purpose

Zinc Oxide 21.50%...... Sunscreen

Uses

Helps protect against sunburn
Higher SPF gives more sunburn protection
provides moderate protection against sunburn

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash and irritation develops and lasts. Avoid contact with eyese. If product gets into eyes, rinse thoroughly with water. Keep out of reach of children. If swallowed, get medicl help or contact poison control center right away.

Directions

Apply evenly to skin before exposure to sun and as needed
Reapply as needed or after towel drying or swimming
Children under 6 months, ask doctor.

Inactive Ingredients

ES SPF 30.jpg

CHEM FREE SPF 30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59958-404
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	21 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	35 g in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O)	12 g in 100 g
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)	8 g in 100 g
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)	2.8 g in 100 g
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)	1.9 g in 100 g
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	1.8 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59958-404-01	50 g in 1 TUBE; Type 0: Not a Combination Product	07/19/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	07/19/2017

Labeler - Owen Biosciences, Inc. (790003045)