Protect and Prime Broad Spectrum SPF30

Product NDC
70453-001
11-digit product format
704530001
Labeler code
70453
Product ID
70453-001_09c78b92-8f3e-7c88-e063-6394a90a370c
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Emma Hardie Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-03
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE
Active strength
30; 75; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Protect and Prime Broad Spectrum SPF30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
OCTINOXATE75 mg/mL
OCTOCRYLENE100 mg/mL
OXYBENZONE60 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 4Y5P7MUD51, 5A68WGF6WM, 95OOS7VE0Y

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]5Current NDC, Legacy NDC, 2 package rows20231111_cdd6ffe3-2ae6-44d8-a9b8-45bb134e928c.zip

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