MINERAL UV SHIELD SPF30- titanium dioxide and zinc oxide cream

Mineral UV Shield SPF30 by

Drug Labeling and Warnings

Mineral UV Shield SPF30 by is a Otc medication manufactured, distributed, or labeled by Omorovicza Kozmetikai Kft.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

ACTIVE INGREDIENTS	PURPOSE
Titanium Dioxide 1.5%	Sunscreen
Zinc Oxide 8.6%	Sunscreen

USES

Protects from UVA/B sunrays

WARNING

For external use only; do not swallow.

Stop use if rash or irritation occurs.

Keep out of reach for children.

When using this product keep out of eyes.

DIRECTIONS

Apply evenly to face and neck. Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating or immediately after towel drying or at least every 2 hours.

INGREDIENTS

Aqua (Hungarian Thermal Water), Caprylic/Capric Triglyceride, Zinc Oxide, Silica, Squalane, Glycerin, Ethylhexyldodecanol, Stearyl Heptanoate, Cetearyl Olivate, Cetearyl Ethylhexanoate, Titanium Dioxide, Sorbitan Olivate, Phenoxyethanol, Ascorbyl Tetraisopalmitate, Cetearyl Alcohol, Saccharomyces (Hungarian Thermal Water) Ferment Extract, Polyhydroxystearic Acid, Disodium EDTA, Alumina, Sodium Hyaluronate, Parfum (Fragrance), Prunus Armeniaca (Apricot) Kernel Oil, Tocopherol, Ethylhexylglycerin, Isostearic Acid, Lactic Acid, Xanthan Gum, Phospholipids, Linalool, Limonene, Citral.

SPL UNCLASSIFIED SECTION

Product of Hungary
www.omorovicza.com
Omorovicza Kft, 2 Andrassy Ut, 1061 Budapest

PRINCIPAL DISPLAY PANEL - 100 ml Tube Box

MINERAL UV SHIELD
SPF 30

Omorovicza
BUDAPEST

e 3.4 fl oz 100ml

INGREDIENTS AND APPEARANCE

MINERAL UV SHIELD SPF30 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41442-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	15 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	86 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Squalane (UNII: GW89575KF9)
Glycerin (UNII: PDC6A3C0OX)
Stearyl Heptanoate (UNII: 2M4UGL1NCN)
Cetearyl Olivate (UNII: 58B69Q84JO)
Cetearyl Ethylhexanoate (UNII: 9M64UO4C25)
Sorbitan Olivate (UNII: MDL271E3GR)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Edetate Disodium (UNII: 7FLD91C86K)
Aluminum Oxide (UNII: LMI26O6933)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Apricot Kernel Oil (UNII: 54JB35T06A)
Tocopherol (UNII: R0ZB2556P8)
Ethylhexylglycerin (UNII: 147D247K3P)
Isostearic Acid (UNII: X33R8U0062)
Lactic Acid (UNII: 33X04XA5AT)
Xanthan Gum (UNII: TTV12P4NEE)
Omega-3 Fatty Acids (UNII: 71M78END5S)
Linalool, (+/-)- (UNII: D81QY6I88E)
Citral (UNII: T7EU0O9VPP)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41442-152-01	1 in 1 BOX
1		100 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2015

Labeler - Omorovicza Kozmetikai Kft. (525432105)

Establishment
Name	Address	ID/FEI	Business Operations
Omorovicza Kozmetikai Kft.		525432105	LABEL(41442-152) , MANUFACTURE(41442-152)