SNUGZ SPF 50 SUNSCREEN STICK- spf 50 sunstick stick 
SnugZ/USA, LLC

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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ZSUN - SPF 50 Sunstick

SnugZ SPF 50 Sunscreen Stick

ZSUN - SPF 50 Sunstick

SNUGZ SPF 50 SUNSCREEN STICK 
spf 50 sunstick stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76309-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.561 g  in 18.7 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.187 g  in 18.7 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.561 g  in 18.7 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76309-500-014.67 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
2NDC:76309-500-5514.8 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/2018
3NDC:76309-500-6618.7 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2018
Labeler - SnugZ/USA, LLC (615959228)
Establishment
NameAddressID/FEIBusiness Operations
SnugZ/USA, LLC615959228manufacture(76309-500)

Revised: 11/2019
Document Id: 972e0395-d970-000c-e053-2995a90a968c
Set id: 6e1179cf-5bfb-1156-e053-2991aa0a5b46
Version: 2
Effective Time: 20191112
 
SnugZ/USA, LLC