ZINXATION SUNSCREEN SPF-50- zinc oxide lotion

ZINXATION SUNSCREEN by

Drug Labeling and Warnings

ZINXATION SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ANTARIA PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE 25%

PURPOSE

SUNSCREEN

USES

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun

WARNINGS

• Avoid prolonged exposure in the sun.
• Wear protective clothing-hats and sunglasses.
• Do not swallow.
• For external use only.
• Avoid contact with eyes.
• If a rash or irritation occurs discontinue use.

DIRECTIONS:

• Apply generously to all areas 20 minutes before sun exposure.
• Reapply every 2 hours or after swimming.

INACTIVE INGREDIENTS

Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA

QUESTIONS OR COMMENTS?

Call +61 73726 2030

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINXATION SUNSCREEN  SPF-50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60396-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT ALKANES (UNII: 1E5KJY107T)
JOJOBA OIL (UNII: 724GKU717M)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
YELLOW WAX (UNII: 2ZA36H0S2V)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENYLPROPANOL (UNII: 0F897O3O4M)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETYL PHOSPHATE (UNII: VT07D6X67O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60396-201-11	100 g in 1 TUBE; Type 0: Not a Combination Product	07/16/2018
2	NDC: 60396-201-12	125 g in 1 TUBE; Type 0: Not a Combination Product	07/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/16/2018

Labeler - ANTARIA PTY LTD (740611405)

Establishment
Name	Address	ID/FEI	Business Operations
ANTARIA PTY LTD		740611405	manufacture(60396-201)