ZINKA CLEAR ZINC OXIDE SUNSCREEN- octinoxate, zinc oxide, octisalate, oxybenzone lotion
Zinka, 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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Zinka Clear Zinc Oxide Sunscreen

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, Caprylyl Glycol, Disodium EDTA, Methylisothiazolinone

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
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)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
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)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52993-001-03	85.1 g in 1 TUBE; Type 0: Not a Combination Product	09/20/2016

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

Labeler - Zinka, Inc. (153569595)

Name	Address	ID/FEI	Business Operations
Establishment
A.I.G. Technologies, Inc.		086365223	manufacture(52993-001) , label(52993-001)

Zinka Clear Zinc Oxide Sunscreen

Active Ingredients

Purposes

​Uses

​Warnings

​When using this product

​Stop use and ask doctor if

​Directions

​Other information