FDA.reportPublic FDA data

Always Foundation Makeup Broad Spectrum SPF 15 Natural Tan

Product NDC
68828-425
11-digit product format
688280425
Labeler code
68828
Product ID
68828-425_adb69111-e5bf-e252-e053-2995a90aa4ca
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
JAFRA COSMETICS INTERNATIONAL
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-08-25
Marketing end
0000-00-00
Substance
ZINC OXIDE; HOMOSALATE; OCTISALATE
Active strength
7 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68828-425IInactivated by FDA2026-07-31
excluded packagepackage68828-42568828-425-01IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YMLABSSPF15 FLAVORED LIP BALMYusef Manufacturing Laboratories6c456df1-db54-481b-b583-186b9bdaf6702026-01-12WarningsExact identifier
OI LIN SUNMILK SUNSCREEN SPF 30SUNSCREEN, TITANIUM DIOXIDESunrider Manufacturing L.P.26b57314-1616-4ca4-b65f-a363c525b4322025-12-29WarningsExact identifier
EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45ZINC OXIDEEthoSun, Incd7d2bca6-5000-4cb9-b004-b1ae286f60352025-06-03WarningsExact identifier
Scar Cream SPF 30AVOBENZONE, OCTOCRYLENE, OXYBENZONEGenomma Lab827d4e72-4bb7-2ec7-e053-2991aa0a983e2019-02-22WarningsExact identifier
Advanced Anti-Wrinkle Therapy CicatricureAVOBENXONE 3%, OCTINOXATE 7.5%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 4%Genomma Lab8153c706-d1bd-6c42-e053-2991aa0afda42019-02-18WarningsExact identifier
ALL WEATHER SPF 15 LIP BALMZINC OXIDEBurt's Bees604f0949-6d6d-b3ea-e053-2a91aa0acc452018-12-17WarningsExact identifier
CLE CCC Golden Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b7a4847f-b84d-4f36-8787-104eccd838a02018-12-03WarningsExact identifier
CLE CCC Warm Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.229c20a3-6288-4ac3-9098-6d1622e906ab2018-11-29WarningsExact identifier
CLE CCC Warm Medium LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.fc90fb8a-44b3-47cd-882e-94ed324ed3892018-11-27WarningsExact identifier
CLE CCC Warm MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b585f216-4234-47c5-9a6b-8b133ef48aae2018-11-27WarningsExact identifier
CLE CCC Warm LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.14891e26-b3b6-4545-99b1-da914b7f56292018-11-24WarningsExact identifier
Glossier sun glaze gleaming sunscreen oil broad spectrum SPF 30 Water Resistant 40 MinGLOSSIER SUN GLAZE GLEAMING SUNSCREEN OIL BROAD SPECTRUM SPF 30 WATER RESISTANT 40 MINGlossier Inc.35e70dcf-a00a-4401-8127-09219931e3ac2018-11-13WarningsExact identifier
Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20Mana Products657d5090-30a8-46d0-879d-469178aa234d2018-01-25WarningsExact identifier
Everyday Sheer Coverage Medium Tint SPF 20ZINC OXIDEAllure Labs Inc89bdf852-9420-4736-b50d-0af55afb6bd32017-12-20WarningsExact identifier
Everyday Sheer Coverage Light Tint SPF 20ZINC OXIDEAllure Labs Incc70a3f80-84a9-4ce7-88a1-4c50d15d758c2017-12-15WarningsExact identifier
Mineral Sunscreen Moisturizer Broad Spectrum SPF 20ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc316c2132-ab81-47f6-8e80-71e9252a26632017-12-12WarningsExact identifier
Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inca149b716-58f5-4da1-b330-f79fa7596c182017-12-12WarningsExact identifier
Mineral Sunscreen Broad Spectrum SPF 45ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc96d2d0f1-dbde-4b66-9b2c-9d07f75470662017-12-11WarningsExact identifier
Pyratine XR Creme With Sunscreen Broad Spectrum SPF30ZINC OXIDEAllure Labs Incfc316b19-c1cf-4b5b-9f22-9672b7d0cbff2017-12-07WarningsExact identifier
Cover Recover SPF 30 IvoryZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incfe207b88-8eb8-424d-89b4-8d5b188dd2c32017-12-05WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings : For external use only. When using this product: • Keep out of eyes • Rinse with water to remove • Stop use and ask a doctor if rash or irritation develops and lasts.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68828-425-012022-01-28C16284748780-1d6a99b39-c81c-a426-e053-dadaa90af4c2Always Foundation Makeup Broad Spectrum SPF 15 Natural Tan

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-425-01Always Foundation Makeup Broad Spectrum SPF 15 Natural Tan30 mL in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-425ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 NATURAL TAN (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]1Legacy NDC, 1 package rows20200826_adb69111-e5be-e252-e053-2995a90aa4ca.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68828-425-016882804250130 mL in 1 TUBE (68828-425-01) 30 ml2020-08-250000-00-00NoNoCurrent