SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-BASHFUL BEIGE- octinoxate, octisalate, titanium dioxide lipstick
INTERCOS EUROPE SPA
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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SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-Bashful Beige
Package Labeling:
![Outer package5](https://fda.report/DailyMed/78d5318a-6e3f-4d79-b0e6-25165f4a055d/Outer+package5.jpg)
![Inner package](https://fda.report/DailyMed/78d5318a-6e3f-4d79-b0e6-25165f4a055d/Inner+package.jpg)
SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-BASHFUL BEIGE
octinoxate, octisalate, titanium dioxide lipstick |
Product Information |
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 63272-506 |
Route of Administration | TOPICAL |
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Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) | OCTINOXATE | 7.125 mg in 1 g |
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) | OCTISALATE | 3 mg in 1 g |
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) | TITANIUM DIOXIDE | 1.83 mg in 1 g |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 63272-506-16 | 1 in 1 CARTON | 12/19/2015 | 12/29/2019 |
1 | | 3.5 g in 1 TUBE; Type 0: Not a Combination Product | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph not final | part352 | 12/19/2015 | 12/29/2019 |
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Labeler - INTERCOS EUROPE SPA
(338578473)
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Establishment |
Name | Address | ID/FEI | Business Operations |
INTERCOS EUROPE SPA | | 339447428 | manufacture(63272-506) |
Establishment |
Name | Address | ID/FEI | Business Operations |
Intercos Europe S.p.A. | | 438961310 | pack(63272-506) |
INTERCOS EUROPE SPA