FDA.reportPublic FDA data

Complexion Protection Moisturizer SPF

Product NDC
70809-1912
Requested package NDC
70809-1912-2
11-digit product format
708091912
Labeler code
70809
Product ID
70809-1912_eadc4845-6383-4a0a-e053-2995a90a970e
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide, octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
USRX LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-04-01
Marketing end
0000-00-00
Substance
OCTISALATE; ZINC OXIDE
Active strength
5 mg/100mL; mg/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70809-191270809-1912-2IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70809-1912-12026-01-29Complexion Protection Moisturizer
70809-1912-22026-01-29Complexion Protection Moisturizer
70809-1912-12023-10-20Complexion Protection Moisturizer
70809-1912-22023-10-20Complexion Protection Moisturizer
70809-1912-12023-07-28Complexion Protection Moisturizer
70809-1912-22023-07-28Complexion Protection Moisturizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70809-1912-1Complexion Protection Moisturizer SPF15 mL in 1 TUBECREAM154
70809-1912-2Complexion Protection Moisturizer SPF1 in 1 BOXCREAM14
70809-1912-2Complexion Protection Moisturizer SPF50 mL in 1 BOTTLECREAM504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70809-1912COMPLEXION PROTECTION MOISTURIZER SPF (ZINC OXIDE, OCTISALATE) CREAM [USRX LLC]4Legacy NDC, 3 package rows20241004_e3103369-39c7-6d4d-e053-2a95a90a5eef.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70809-1912-2708091912021 BOTTLE in 1 BOX (70809-1912-2) > 50 mL in 1 BOTTLE1 bottle2022-04-010000-00-00NoNoCurrent