SHIELD- zinc oxide cream

Shield by

Drug Labeling and Warnings

Shield by is a Otc medication manufactured, distributed, or labeled by Bellus Medical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 21%

PURPOSE

Sunscreen

WARNINGS

For external use only. Do not use on damaged or broken skin. Stop use and ask doctor if rash and irritation develops and lasts.

Avoid contact with eyes if product gets into eyes rinse thoroughly with water.

If swallowed get medical help or contact poison control center right away.

INDICATIONS & USAGE

Evenly apply to skin before
exposure to sun and as needed.
Children under 6 months,
ask doctor.
Protect this product from
excessive heat and direct sun.

INACTIVE INGREDIENT

Argania Spinosa Kernel Oil, Caprylic/
Capric Triglyceride, Cetearyl
Alcohol, Cetearyl Glucoside,Cetearyl
Olivate, Coco-Caprylate/-
Caprate , Cocoglycerides, Coconut
Alkanes , Copernicia Cerifera
(Carnauba) Wax, Diethylhexanoate,
Ethyl Macadamiate, Glycerin, Glyceryl
Caprylate, Glyceryl Isostearate,
Glyceryl Undecylenate, Iron
Oxides, Lysolecithin, Neopentyl
Glycol, p-Anisic acid, Polyglyceryl-3
Polyricinoleate, Polyglyceryl-3
Stearate, Polyhydroxystearic Acid,
Potassium Cetyl Phosphate, Propanediol,
Simmondsia Chinensis
(Jojoba) Seed Oil, Sodium Chloride,
Sorbitan Olivate, Tocopherol Linoleate
/ Oleate, Triethoxycaprylylsilane,
Water (Aqua), Xanthan Gum.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHIELD 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71888-104
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
COCO-CAPRYLATE (UNII: 4828G836N6)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
WATER (UNII: 059QF0KO0R)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN OLIVATE (UNII: MDL271E3GR)
JOJOBA OIL (UNII: 724GKU717M)
XANTHAN GUM (UNII: TTV12P4NEE)
COCONUT ALKANES (UNII: 1E5KJY107T)
PROPANEDIOL (UNII: 5965N8W85T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERYL TRICAPRYLATE (UNII: 6P92858988)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71888-104-01	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2015

Labeler - Bellus Medical, LLC (005677967)

Registrant - Bellus Medical, LLC (005677967)

Establishment
Name	Address	ID/FEI	Business Operations
Owen Biosciences Inc.		790003045	manufacture(71888-104)