DR ZINX BRIGHTENING MINERAL 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.

----------

DR ZINX BRIGHTENING MINERAL SUNSCREEN - SPF-50

ACTIVE INGREDIENT

ZINC OXIDE (25.0% W/W)

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

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
Stop use and ask doctor if rash occurs

DIRECTIONS

• apply liberally and evenly 20 minutes before sun exposure
• reapply:

  •      After 40 minutes of swimming or sweating
  •      Immediately after towel drying
  •      at least every 2 hours

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
•    limit time in the sun, especially from 10 a.m. – 2 p.m.
•    wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: ask a doctor

OTHER INFORMATION

Store at temperatures below 90°F (30°C). Protect the product in this container from expressive heat and direct sun.

INACTIVE INGREDIENTS

Demineralised water, Coco-Caprylate/Caprate, Glycerine, C12-C19 Alkane, Simmondia Chinesis (Jojoba) Seed Oil, Polyglyceryl -3-Polyricinoleate, Citrus Unshiu Peel Extract, Cera Alba, Isotearic Acid, Polyhydroxystearic Acid, Maltodextrin, Tocopherol, Caprylyl Glycol, Propanediol, Cetyl Phosphate, Sodium Choride, Disodium EDTA, Ethylhexylglycerin

QUESTIONS?

CONTACT@DRZINX.COM

01b LBL_DrZinx 50ml Whitening  USA

DR ZINX BRIGHTENING MINERAL SUNSCREEN  SPF-50
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60396-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
JOJOBA OIL (UNII: 724GKU717M)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
TANGERINE PEEL (UNII: JU3D414057)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60396-212-1150 mL in 1 TUBE; Type 0: Not a Combination Product05/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/28/202005/28/2020
Labeler - ANTARIA PTY LTD (743874997)
Establishment
NameAddressID/FEIBusiness Operations
ANTARIA PTY LTD743874997manufacture(60396-212)

Revised: 11/2020
 
ANTARIA PTY LTD