Home NDC 69219-108 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Ingredient Strength TITANIUM DIOXIDE 1.3 g/100g ZINC OXIDE 15.3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69219-108-01 Extreme Protect SPF 40All Shades 100 g in 1 BOTTLE, PLASTIC CREAM 100 4 69219-108-02 Extreme Protect SPF 40All Shades 5 g in 1 BOTTLE, PLASTIC CREAM 5 4 69219-108-03 Extreme Protect SPF 40All Shades 240 g in 1 BOTTLE, PLASTIC CREAM 240 4 69219-108-11 Extreme Protect SPF 40All Shades 1 in 1 BOX CREAM 1 4 69219-108-21 Extreme Protect SPF 40All Shades 1 in 1 BAG CREAM 1 4 69219-108-31 Extreme Protect SPF 40All Shades 1 in 1 BOX CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69219-108 EXTREME PROTECT SPF 40 ALL SHADES (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [SCIENCE OF SKINCARE, LLC.] 4 Current NDC, Legacy NDC, 6 package rows 20250112_b69db78b-5f0e-8ca2-e053-2a95a90ac88c.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69219-108-01 69219010801 100 g in 1 BOTTLE, PLASTIC (69219-108-01) 100 g 2021-04-01 0000-00-00 No No Current 69219-108-02 69219010802 5 g in 1 BOTTLE, PLASTIC 5 g Historical 69219-108-03 69219010803 240 g in 1 BOTTLE, PLASTIC (69219-108-03) 240 g 2021-04-01 0000-00-00 No No Current 69219-108-11 69219010811 1 BOTTLE, PLASTIC in 1 BOX (69219-108-11) / 100 g in 1 BOTTLE, PLASTIC (69219-108-01) 2021-04-01 0000-00-00 No No Current 69219-108-21 69219010821 1 BOTTLE, PLASTIC in 1 BAG (69219-108-21) / 5 g in 1 BOTTLE, PLASTIC (69219-108-02) 2021-03-02 0000-00-00 No No Current 69219-108-31 69219010831 1 BOTTLE, PLASTIC in 1 BOX (69219-108-31) / 240 g in 1 BOTTLE, PLASTIC (69219-108-03) 2021-03-01 0000-00-00 No No Current