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 73 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade SevenZINC OXIDEClean Beauty For All, Inc (dba Saie)310a07bb-d32a-401f-955e-4c2860148a302026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade FiveZINC OXIDEClean Beauty For All, Inc (dba Saie)39ae4a97-7f96-4c95-a6de-0c779764fb022026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922fc3e-055c-e51d-e063-6294a90a00f52026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade NineZINC OXIDEClean Beauty For All, Inc (dba Saie)9c7a31df-5bdd-403b-b807-1d1a801e1bb62026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade OneZINC OXIDEClean Beauty For All, Inc (dba Saie)1922fc51-ae53-acb8-e063-6394a90a14eb2026-01-20WarningsExact identifier
application number: M020
Wrinkle Repair Moisturizer SPF 30 EQBAVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2%Walmarta067e968-e598-40ef-95f2-c338b5e413dd2026-01-20WarningsExact identifier
application number: M020
Welmedix HomeCare PRO Fragile Skin Dual Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEWelmedix LLC48da4589-0f5a-c25b-e063-6394a90ac18b2026-01-20WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen KidsZINC OXIDE 14.69%S&C Hampton Sun LLC0bdb7d15-dc52-4e23-9417-fe73f17f61102026-01-20WarningsExact identifier
application number: M020
DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICKOCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATEDEWYTREE CO. ,LTD48406e68-eefd-d2c2-e063-6394a90a4ad92026-01-20WarningsExact identifier
application number: M020
KONEUK SUNSCREEN SPF50KONEUK SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.48dd7f6e-2a4d-2c92-e063-6294a90a42552026-01-20WarningsExact identifier
application number: M020
CHUDAAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEPremier Ocher LLC1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f2026-01-20WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
application number: M020
PROJECT REEF SPF-30 Mineral SunscreenZINC OXIDEProject Reef LLCa6077e6f-d987-4159-946f-3e23972476592026-01-19WarningsExact identifier
application number: M020
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
application number: M020
SABAL Mineral Sunscreen Broad Sprectrum SPF 30ZINC OXIDESABAL SUN LLCf917b446-4e10-4231-826e-fdac32e111862026-01-19WarningsExact identifier
application number: M020
Plius Daily SPF Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEPLIUS, Inc31866de9-afa0-4c11-be65-b613735514932026-01-19WarningsExact identifier
application number: M020
PROTEKT SPF-50 Sheer Mineral SunscreenZINC OXIDEProtekt Products, Inc.6edc0941-bb21-4797-a875-81f7276947742026-01-19WarningsExact identifier
application number: M020
Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21)ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20%Grace and Fire USA Inc.48c1b93c-9c6f-95aa-e063-6294a90a0cfa2026-01-19WarningsExact identifier
application number: M020
ANUA INVISIBLE GLOW FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.446ac344-1078-4cd1-e063-6294a90a4bd42026-01-19WarningsExact identifier
application number: M020
ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.31af7b5e-2bd6-63ee-e063-6294a90a08062026-01-19WarningsExact 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