FDA.reportPublic FDA data

Alpha-H Total Eclipse

Product NDC
55528-400
11-digit product format
555280400
Labeler code
55528
Product ID
55528-400_43908af3-3a7d-4e13-e063-6394a90a47c2
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Alpha-H
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-05
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
9.7; 19.4 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Alpha-H Total Eclipse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE9.7 mg/mL
TITANIUM DIOXIDE19.4 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc8a4efe-7d5e-5f44-e053-6394a90a80aaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55528-400-01Alpha-H Total Eclipse40 mL in 1 TUBELOTION404
55528-400-02Alpha-H Total Eclipse1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55528-400ALPHA-H TOTAL ECLIPSE (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ALPHA-H]2Current NDC, 2 package rows20241009_fc8a4efe-7d5e-5f44-e053-6394a90a80aa.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 40 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf45f7953-c103-4900-e053-2a95a90ae3992026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c888ce-3a3f-972b-e053-2a95a90a4fe32026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKNI TINTPML NYC, LLCf4c44eb6-0a3d-2848-e053-2a95a90a58f32026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8925c-ac54-43b1-e053-2995a90a916c2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8b011-5e1d-378c-e053-2a95a90a09cf2026-04-18WarningsExact identifier
application number: M020
EltaMD UV Daily SPF40ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.d967b7d0-453a-4420-886a-70ecf46528d22026-04-17WarningsExact identifier
application number: M020
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
application number: M020
HOLIKA HOLIKA ALOE CICA UV Defense SunscreenAVOBENZONE, HOMOSALATE, OCTISALATEEnprani Co., Ltd.4fa30449-5332-1492-e063-6394a90a585f2026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
application number: M020
FORGESKINMINERAL TALLOW SUNSCREENGUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD4fa7e67d-cfc5-9f73-e063-6394a90ada502026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.80c60ffa-69e0-4b31-bd0d-fc8ff9936ba02026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.0e18d601-700a-4c1c-a434-22582253bd952026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion BronzeTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.ddb3aa5e-cd1a-4792-b1b1-3604b368e0102026-04-17WarningsExact identifier
application number: M020
House of Colour Tinted Sunscreen SPF 50ZINC OXIDEHouse of Colour, Inc.763f5534-cda1-43f2-8a37-1eaa6a43c2e82026-04-17WarningsExact identifier
application number: M020
Sugargirl SPF 30 Sunscreen Illuminating Stick SunlightHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC28c9f019-34fe-4568-ba35-38eb3c4cb19e2026-04-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55528-400-015552804000140 mL in 1 TUBE40 mlHistorical
55528-400-02555280400021 TUBE in 1 CARTON (55528-400-02) / 40 mL in 1 TUBE (55528-400-01) 1 tube2023-05-05NoNoCurrent