ZINXATION SUNSCREEN SPF-50- zinc oxide lotion
ASTIVITA LIMITED

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.

----------

ZINXATION SUNSCREEN LOTION SPF-50

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

01b LBL_Astiva_ZinXation Face and Body_SPF-50_Page_1

01b LBL_Astiva_ZinXation Face and Body_SPF-50_Page_2

ZINXATION SUNSCREEN SPF-50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80982-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80982-001-38	100 g in 1 TUBE; Type 0: Not a Combination Product	07/16/2018

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

Labeler - ASTIVITA LIMITED (742799513)

Name	Address	ID/FEI	Business Operations
Establishment
ASTIVITA LIMITED		742799513	label(80982-001) , manufacture(80982-001)