Zinka Clear Zinc Oxide Sunscreen (Octinoxate, Zinc Oxide, Octisalate, Oxybenzone) Lotion [Zinka, Inc.] -

ZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]
PDF | XML

View All Sections

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

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
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 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)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	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)

View All Sections

Medic