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 72 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sky and Sol Face and Body Sunscreen Spf 30ZINC OXIDEDelta Ecommerce LLC47dbcf07-7e3a-e3de-e063-6294a90a2c212026-01-21WarningsExact identifier
application number: M020
sunscreenTITANIUM DIOXIDEGuangdong Zhoubang Biotechnology Co., Ltd48f13b1c-8104-881b-e063-6394a90a816d2026-01-21WarningsExact identifier
application number: M020
Sunscreen lip balmETHYLHEXYL SALICYLATEGuangdong Zhoubang Biotechnology Co., Ltd48f1ee5c-33d0-818c-e063-6294a90a1e592026-01-21WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen MotherCEILE SPF 30 PRIME PROTECT RADIATE MOTHERLE COSMETICS INC490db6ef-d7f2-446c-e063-6294a90af3032026-01-21WarningsExact identifier
application number: M020
DewyVita Zero Spot SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEBAREUNPLAN CO.,LTD.497c98c3-d809-52e0-e063-6294a90acca22026-01-21WarningsExact identifier
application number: M020
Mario Badescu The Moisture Magnet SPF 15OCTINOXATE, OXYBENZONE, AVOBENZONEBentley Laboratories LLC4c0b4733-96ea-4b1d-8a7b-13af66cc28d02026-01-21WarningsExact identifier
application number: M020
Sensitif Renewal Cream Daily Protection SPF 30 Broad Spectrum UVA UVB SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERV Skincare LLC86b46c9b-6573-439b-b38b-2d76d495df6d2026-01-20WarningsExact identifier
application number: M020
Perfectif Even Skin Tone Cream Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERV Skincare LLC1b8cf189-0d06-4e86-bd7b-b77a638f16702026-01-20WarningsExact identifier
application number: M020
Bella s Friends SPF50 SunscreenZINC OXIDEPANERGYTEKUSAINC48ce4ef7-e24a-4894-e063-6294a90a49c82026-01-20WarningsExact identifier
application number: M020
Christian Dior Invisible UV Fluid with Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Dior93a27f09-14e2-47a0-ac5f-4d3425e31ec92026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade TenZINC OXIDEClean Beauty For All, Inc (dba Saie)d00b978d-1682-4cde-ae5f-189e677136c42026-01-20WarningsExact identifier
application number: M020
Saie Sunvisor Broad Spectrum SPF 35 Sheer MoisturizerZINC OXIDEClean Beauty For All, Incb6bfd636-2f46-3fca-e053-2a95a90a05a62026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwoZINC OXIDEClean Beauty For All, Inc (dba Saie)19230647-29a3-d209-e063-6394a90aae362026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)8e2a2046-13e6-4a40-a0bc-65c979c59b932026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade EightZINC OXIDEClean Beauty For All, Inc (dba Saie)dbc4242a-3651-48be-bfc6-c595be5a2a152026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922f11d-10ce-82b4-e063-6394a90a66502026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade FourZINC OXIDEClean Beauty For All, Inc (dba Saie)1922e001-e699-7ac5-e063-6394a90a25d92026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade SixZINC OXIDEClean Beauty For All, Inc (dba Saie)a9350360-7932-459f-806c-399fa265e6c02026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade ThreeZINC OXIDEClean Beauty For All, Inc (dba Saie)1923067f-1ab9-d168-e063-6394a90adbd02026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922ee84-d7d0-80b1-e063-6394a90acf7b2026-01-20WarningsExact 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