ZINKA CLEAR ZINC OXIDE SUNSCREEN- octinoxate, zinc oxide, octisalate, oxybenzone lotion

Zinka Clear Zinc Oxide Sunscreen by

Drug Labeling and Warnings

Zinka Clear Zinc Oxide Sunscreen by is a Otc medication manufactured, distributed, or labeled by Zinka, Inc., A.I.G. Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 5.0% w/w

Zinc Oxide 4.3% w/w

Octisalate 3.0% w/w

Oxybenzone 2.5% w/w

Purposes

Sunscreen

​Uses

• Helps prevent sunburn and skin damage caused by UVA/UVB exposure
• Higher SPF gives more sunburn protection

​Warnings

For external use only

​When using this product

• Keep out of eyes.  Rinse with water to remove
• Do not use if allergic to any ingredient
• Keep out of reach of children
• If swallowed, contact Poison Control Center immediately

​Stop use and ask doctor if

• Rash or irritation develops and lasts

​Directions

• Apply liberally 20 minutes before sun exposure to dry skin
• Reapply to dry skin after toweling, swimming or sweating
• For children under 6 months of age: Ask a doctor

​Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

​Inactive Ingredients

Water, Isopropyl Myristate, Aloe Barbadensis Leaf Extract, Diisostearoyl Polyglyceryl-3 Diisostearate, Hydrogenated Polyisobutene, Cetyl Dimethicone, Octyl Palmitate, Retinyl Palmitate, Tocopheryl Acetate, Magnesium Sulfate, Propylene Glycol, White Bees Wax, Hydrogenated Castor Oil, Diazolidinyl Urea, Methyparaben, Disodium EDTA, Propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINKA CLEAR ZINC OXIDE SUNSCREEN 
octinoxate, zinc oxide, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52993-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	43 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
MAGNESIUM SULFATE (UNII: DE08037SAB)
WHITE WAX (UNII: 7G1J5DA97F)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52993-001-03	85.1 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2007

Labeler - Zinka, Inc. (153569595)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies, Inc.		171837367	manufacture(52993-001)