FDA.reportPublic FDA data

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.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage69219-108-21
excluded packagepackage69219-108-11
excluded packagepackage69219-108-31
excluded packagepackage69219-108-03
excluded packagepackage69219-108-01

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
IngredientStrength
TITANIUM DIOXIDE1.3 g/100g
ZINC OXIDE15.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b69db78b-5f0e-8ca2-e053-2a95a90ac88cAvailable on FDA.report

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

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 151 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everyday Humans Sunscreen Lip Balm Broad Spectrum SPF30LIP BALM SPF30Everyday Group Limted2d42034a-4ada-57cf-e063-6394a90a0b5f2025-12-04WarningsExact identifier
application number: M020
Ciele SPF 30 prime PROTECT Broad Spectrum SPF 30 SunscreenSUNSCREEN 30 MINERALLE COSMETICS INC3bb54b93-0ab2-2ecc-e063-6394a90acac32025-12-04WarningsExact identifier
application number: M020
Good Times SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEEVERYDAY GROUP LIMITEDf40c6c4a-47a2-5dfe-e053-2995a90a3df32025-12-04WarningsExact identifier
application number: M020
Sheer Guard Natural Mineral SunscreenZINC OXIDEEVERYDAY GROUP LIMITED3257719d-dcc6-7ac5-e063-6294a90aafcd2025-12-04WarningsExact identifier
application number: M020
Sun Glazed SPF 30 Sunscreen Glow OilAVOBENZONE, HOMOSALATE, OCTOCRYLENEEVERYDAY GROUP LIMITEDdba8075b-be36-4787-b23d-942d0e792aa82025-12-04WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 DeepZINC OXIDECrunchi, LLC.0dc478e0-9555-4ce6-b448-7d58e3a6bae02025-12-04WarningsExact identifier
application number: M020
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
application number: M020
Solbar Thirty SPF 30SOLBAR THIRTY SPF30Person and Coveyab9ac056-61d9-43d5-a3db-2d487897cc692025-12-04WarningsExact identifier
application number: M020
Solbar Fifty SPF50SOLBAR FIFTY SPF50Person and Covey41fd3844-181c-4cb2-8379-f313104351ef2025-12-04WarningsExact identifier
application number: M020
Solbar Avo SPF35SOLBAR AVO SPF35Person and Coveybfe1e828-76d4-4db3-a8ba-b54b31baacad2025-12-04WarningsExact identifier
application number: M020
Banana Boat Sport Ultra Broad Spectrum SPF 50 Plus Sunscreen Lip BalmAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7a3c03b-7fee-404c-e053-2a95a90a3a972025-12-04WarningsExact identifier
application number: M020
Poolside Bronze Service Instant bronzing lotion. SPF30HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4524129b-f8aa-171b-e063-6294a90aeebe2025-12-04WarningsExact identifier
application number: M020
Solbar Zinc SPF38SOLBAR ZINC SPF38Person and Coveyfac62a2f-92ee-4afd-9999-bc5011159e432025-12-04WarningsExact identifier
application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me GirlZINC OXIDEe.l.f. Cosmetics, Inc.6c316ce4-c2f6-4633-a789-e786d0f76abd2025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen coconut SPF 15 Scented lip glossHOMOSALATE, OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b5f2c-b61f-8915-e063-6294a90ac9112025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen watermelon SPF 15 Scented lip glossHOMOSALATE , OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b6e12-1bf9-8093-e063-6394a90a9e742025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip glossHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b6f22-5080-86ab-e063-6394a90a04162025-12-04WarningsExact identifier
application number: M020
Poolside Golden Hour SPF15 sunscreen lip oilHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b8393-1887-a660-e063-6394a90a4c2b2025-12-04WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 shimmer sunscreen gelHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b8dde-dd63-b585-e063-6394a90a35432025-12-04WarningsExact identifier
application number: M020
Binda Botanicals Baby and Kids Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED452b9b7d-4049-b483-e063-6394a90a53582025-12-04WarningsExact identifier
application number: M020

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