ZINXATION SUNSCREEN SPF-50- zinc oxide lotion 
ANTARIA PTY LTD

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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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

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ZINXATION SUNSCREEN  SPF-50
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60396-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60396-201-11100 g in 1 TUBE; Type 0: Not a Combination Product07/16/201811/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/16/201811/25/2020
Labeler - ANTARIA PTY LTD (743874997)
Establishment
NameAddressID/FEIBusiness Operations
ANTARIA PTY LTD740611405manufacture(60396-201)

Revised: 11/2020
Document Id: b4e85227-8c55-521e-e053-2a95a90a81a6
Set id: 84dc3c8a-8ab7-4a5c-ab62-beb29aade9ed
Version: 8
Effective Time: 20201125
 
ANTARIA PTY LTD