FDA.reportPublic FDA data

Protect and Prime Broad Spectrum SPF30

Product NDC
70453-001
Requested package NDC
70453-001-01
11-digit product format
704530001
Labeler code
70453
Product ID
70453-001_ed163f32-52c4-0873-e053-2995a90a6af9
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Emma Hardie Ltd
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-02-03
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE
Active strength
30 mg/mL; mg/mL; mg/mL; mg/mL
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 packagepackage70453-00170453-001-01DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70453-001-01Protect and Prime Broad Spectrum SPF301 in 1 BOXCREAM15
70453-001-01Protect and Prime Broad Spectrum SPF3050 mL in 1 BOTTLECREAM505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70453-001PROTECT AND PRIME BROAD SPECTRUM SPF30 (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [EMMA HARDIE LTD]5Legacy NDC, 2 package rows20231111_cdd6ffe3-2ae6-44d8-a9b8-45bb134e928c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protect and Prime Broad Spectrum SPF30AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONEEmma Hardie Ltdcdd6ffe3-2ae6-44d8-a9b8-45bb134e928c2023-11-10WarningsExact identifier
ndc (package): 70453-001-01
ndc (product): 70453-001
ndc11 (package): 70453000101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70453-001-01704530001011 BOTTLE in 1 BOX (70453-001-01) > 50 mL in 1 BOTTLE1 bottle2016-02-030000-00-00NoNoCurrent