DISNEY FROZEN SPF LIP SMACKER LIP BALM- padimate o, oxybenzone, octinoxate stick
Markwins Beauty Products, Inc
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.
----------
Principal Display Panel
![Principal Display Panel](https://fda.report/DailyMed/2c11bb07-0615-20b1-e054-00144ff8d46c/DSPF24_FROZEN_TRIO_CARD.jpg)
DISNEY FROZEN SPF LIP SMACKER LIP BALM
padimate o, oxybenzone, octinoxate stick |
Product Information |
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 12027-201 |
Route of Administration | TOPICAL |
|
Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) | PADIMATE O | 8 g in 100 g |
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) | OCTINOXATE | 7.5 g in 100 g |
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) | OXYBENZONE | 6 g in 100 g |
|
|
|
Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 12027-201-02 | 1 in 1 BLISTER PACK | 02/18/2016 | 01/01/2019 |
1 | NDC: 12027-201-01 | 4 g in 1 TUBE; Type 0: Not a Combination Product | | |
|
|
Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part352 | 02/18/2016 | 01/01/2019 |
|
Labeler - Markwins Beauty Products, Inc
(135407760)
|
Markwins Beauty Products, Inc