FDA.reportPublic FDA data

Sunceutical SPF 50 Mineral Face Cream

Product NDC
70157-369
11-digit product format
701570369
Labeler code
70157
Product ID
70157-369_5a5bb1b1-67c1-0ec4-e063-6294a90a2a37
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Baxter Laboratories Pty. Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-21
Substance
ZINC OXIDE
Active strength
20 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Sunceutical SPF 50 Mineral Face Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
2c408728-a1de-d51e-e063-6294a90ade0bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70157-369-01Sunceutical SPF 50 Mineral Face Cream50 mL in 1 JARCREAM501
70157-369-02Sunceutical SPF 50 Mineral Face Cream1 in 1 CARTONCREAM11
70157-369-03Sunceutical SPF 50 Mineral Face Cream50 mL in 1 CUPCREAM501
70157-369-04Sunceutical SPF 50 Mineral Face Cream1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70157-369SUNCEUTICAL SPF 50 MINERAL FACE CREAM (ZINC OXIDE) CREAM [BAXTER LABORATORIES PTY. LTD.]1Current NDC, 4 package rows20250124_2c408728-a1de-d51e-e063-6294a90ade0b.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 124 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lip CrackTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37edc05c-82c3-90fe-e063-6294a90aa6012025-12-15Exact identifier
application number: M020
Restore And ReplenishZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ed8525-6ae4-4e86-e063-6294a90afeb82025-12-15Exact identifier
application number: M020
Sunshade Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee77dc-a96a-5efa-e063-6394a90affda2025-12-15Exact identifier
application number: M020
Sunshade Mineral SunscreenZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37df21f1-f36f-df43-e063-6294a90aea6f2025-12-15Exact identifier
application number: M020
Tinted Moisturizing Mineral SunscreenZINC OXIDEEDIT EUROSPA, LLC3751861d-3f3b-2ebd-e063-6294a90af8982025-12-15Exact identifier
application number: M020
Non Tinted Moisturizing Mineral SunscreenZINC OXIDEEDIT EUROSPA, LLC3751e278-b8b2-7bf4-e063-6394a90a42902025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37521c60-2fee-861e-e063-6294a90ad69a2025-12-15Exact identifier
application number: M020
MATTE Non Tinted Mineral SunscreenZINC OXIDEAllure Esthetics3725d947-b1fa-3b50-e063-6394a90adf102025-12-15Exact identifier
application number: M020
GLOW Tinted Mineral SunscreenZINC OXIDEAllure Esthetics37257bb2-d91d-6ff8-e063-6294a90a01b62025-12-15Exact identifier
application number: M020
Daily RestoreZINC OXIDETYRLIN ENTERPRISES, INC.35ce7133-badb-1bc4-e063-6294a90a74782025-12-15Exact identifier
application number: M020
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bee5f9-68d6-6302-e063-6394a90ada882025-12-15Exact identifier
application number: M020
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bfd54a-d7b7-f1a7-e063-6294a90a039b2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c03804-04e9-3d54-e063-6294a90a34072025-12-15Exact identifier
application number: M020
Deflectin Tinted Mineral SunscreenZINC OXIDEAEON AESTHETICS LLC35d14660-8900-2cb0-e063-6394a90a317d2025-12-15Exact identifier
application number: M020
Mineral Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf36c1-50c9-e848-e063-6294a90a66582025-12-15Exact identifier
application number: M020
Flash Invisible StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d2489e-4978-4fc3-e063-6294a90adfcc2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c010ad-e25d-f197-e063-6294a90a0efb2025-12-15Exact identifier
application number: M020
Flash Tinted StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d28590-e746-7996-e063-6294a90ac7d82025-12-15Exact identifier
application number: M020
Mineral Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf03f4-200a-5643-e063-6394a90a9e022025-12-15Exact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf708c-244e-63a8-e063-6394a90a3b962025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70157-369-017015703690150 mL in 1 JAR50 mlHistorical
70157-369-02701570369021 JAR in 1 CARTON (70157-369-02) / 50 mL in 1 JAR (70157-369-01) 1 jar2025-01-21NoNoCurrent
70157-369-037015703690350 mL in 1 CUP50 mlHistorical
70157-369-04701570369041 CUP in 1 CARTON (70157-369-04) / 50 mL in 1 CUP (70157-369-03) 1 cup2025-01-21NoNoCurrent
70157-369-05701570369055 mL in 1 PACKET (70157-369-05) 5 ml2026-09-03YesNoCurrent