ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30

Product NDC
42851-060
11-digit product format
428510060
Labeler code
42851
Product ID
42851-060_25a24c79-21ec-795b-e063-6294a90a7b97
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
ZO Skin Health, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-31
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
10; 200 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage42851-060-15
excluded packagepackage42851-060-30
excluded packagepackage42851-060-75

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
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE10 mg/mL
ZINC OXIDE200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
9a4f5be1-da04-48b9-897a-57f4a3d9d1ecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-060-15ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 301 in 1 CARTONCREAM18
42851-060-15ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 3015 mL in 1 BOTTLE, PUMPCREAM158
42851-060-30ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 301 in 1 CARTONCREAM18
42851-060-30ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 3030 mL in 1 BOTTLE, PUMPCREAM308
42851-060-75ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 301 in 1 CARTONCREAM18
42851-060-75ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 3075 mL in 1 BOTTLE, PUMPCREAM758

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-060ZO SKIN HEALTH SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [ZO SKIN HEALTH, INC.]8Current NDC, Legacy NDC, 6 package rows20241031_9a4f5be1-da04-48b9-897a-57f4a3d9d1ec.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 44 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Abib Dewy tinted sunscreen Glow tube LightOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f165895-aa84-e215-e063-6394a90a62562026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube MediumOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f16b8a4-4279-5f79-e063-6294a90a353d2026-04-10WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLCf5ca0416-548c-4be0-a69e-c7e1b52aba952026-04-10Warnings, Adverse reactionsExact identifier
application number: M020
LASPA TINTED MATTE SUNSCREEN SPF 20 LIGHTZINC OXIDEThe Green Cricket Incc56fd135-f46a-51ce-e053-2a95a90ab7b32026-04-10WarningsExact identifier
application number: M020
CorTex SunX 50 ThickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Incf67a6c6c-c314-1c9d-e053-2a95a90a7f1a2026-04-10WarningsExact identifier
application number: M020
Nu Skin 180 Degree UV Block Hydrator SPF 18OCTINOXATE AND ZINC OXIDENSE Products, Inc.b9635e59-bb08-4167-b7ba-54c3fc7125892026-04-09WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.79c6fe2a-34c2-44cc-81bc-796c4463d2a62026-04-09Warnings, Adverse reactionsExact identifier
application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fdbae5-84ec-7b1d-e063-6294a90a28782026-04-09WarningsExact identifier
application number: M020
Arizona Sun Prickly Pear Lip Balm SPF 15SUNSCREEN LIP BALMArizona Sun Products11e9cb25-6ff8-a121-e063-6394a90a849e2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 8SUNSCREENArizona Sun Products11e8b612-29be-47ed-e063-6394a90ab9e72026-04-09WarningsExact identifier
application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fdcfd0-8b24-7efc-e063-6294a90af7fa2026-04-09WarningsExact identifier
application number: M020
Arizona Sun SPF 45 Cycleblok SunscreenSUNSCREENArizona Sun Products11e71a84-12d1-2d4f-e063-6294a90adcd62026-04-09WarningsExact identifier
application number: M020
Arizona Sun SPF 45 Bikerblok SunscreenSUNSCREENArizona Sun Products11e6eafd-f967-b748-e063-6394a90aabfd2026-04-09WarningsExact identifier
application number: M020
YSE Beauty Skin Glow Primer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLC6a318e27-14e5-488e-ac19-010f69cb743d2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Kids Water Resistant SPF 30SUNSCREENArizona Sun Products116ed17c-3b38-5e96-e063-6294a90a42462026-04-09WarningsExact identifier
application number: M020
Arizona Sun SPF 45 Surfblok SunscreenSUNSCREENArizona Sun Products11e76815-9316-555d-e063-6294a90aeb812026-04-09WarningsExact identifier
application number: M020
Arizona Sun Moisturizer SPF 3MOISTURIZERArizona Sun Products1171af26-3040-552c-e063-6294a90ae2202026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF15SUNSCREENArizona Sun10a600aa-4faa-47fc-e063-6294a90ac4ef2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Water Resistant SPF 30SUNSCREENArizona Sun Products11334e45-4bc2-d597-e063-6294a90a323e2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Water Resistant SPF 30SUNSCREENArizona Sun Products1148e719-b8ed-11b3-e063-6394a90ac1162026-04-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42851-060-15428510060151 BOTTLE, PUMP in 1 CARTON (42851-060-15) / 15 mL in 1 BOTTLE, PUMP2019-10-310000-00-00NoNoCurrent
42851-060-30428510060301 BOTTLE, PUMP in 1 CARTON (42851-060-30) / 30 mL in 1 BOTTLE, PUMP2019-10-310000-00-00NoNoCurrent
42851-060-75428510060751 BOTTLE, PUMP in 1 CARTON (42851-060-75) / 75 mL in 1 BOTTLE, PUMP2019-10-310000-00-00NoNoCurrent