Extreme Protect SPF 40

Product NDC
69219-108
11-digit product format
692190108
Labeler code
69219
Product ID
69219-108_2b4f67e8-6794-c22e-e063-6394a90ac9ac
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Science of Skincare, LLC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
1.3; 15.3 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extreme Protect SPF 40
Brand name suffix
All Shades
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE1.3 g/100g
ZINC OXIDE15.3 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69219-108-01Extreme Protect SPF 40All Shades100 g in 1 BOTTLE, PLASTICCREAM1004
69219-108-02Extreme Protect SPF 40All Shades5 g in 1 BOTTLE, PLASTICCREAM54
69219-108-03Extreme Protect SPF 40All Shades240 g in 1 BOTTLE, PLASTICCREAM2404
69219-108-11Extreme Protect SPF 40All Shades1 in 1 BOXCREAM14
69219-108-21Extreme Protect SPF 40All Shades1 in 1 BAGCREAM14
69219-108-31Extreme Protect SPF 40All Shades1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69219-108EXTREME PROTECT SPF 40 ALL SHADES (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [SCIENCE OF SKINCARE, LLC.]4Current NDC, Legacy NDC, 6 package rows20250112_b69db78b-5f0e-8ca2-e053-2a95a90ac88c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69219-108-0169219010801100 g in 1 BOTTLE, PLASTIC (69219-108-01) 100 g2021-04-010000-00-00NoNoCurrent
69219-108-02692190108025 g in 1 BOTTLE, PLASTIC5 gHistorical
69219-108-0369219010803240 g in 1 BOTTLE, PLASTIC (69219-108-03) 240 g2021-04-010000-00-00NoNoCurrent
69219-108-11692190108111 BOTTLE, PLASTIC in 1 BOX (69219-108-11) / 100 g in 1 BOTTLE, PLASTIC (69219-108-01) 2021-04-010000-00-00NoNoCurrent
69219-108-21692190108211 BOTTLE, PLASTIC in 1 BAG (69219-108-21) / 5 g in 1 BOTTLE, PLASTIC (69219-108-02) 2021-03-020000-00-00NoNoCurrent
69219-108-31692190108311 BOTTLE, PLASTIC in 1 BOX (69219-108-31) / 240 g in 1 BOTTLE, PLASTIC (69219-108-03) 2021-03-010000-00-00NoNoCurrent