FDA.reportPublic FDA data

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
42851-060-152022-10-06ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
42851-060-302022-10-06ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
42851-060-752022-10-06ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
42851-060-152022-07-29ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
42851-060-302022-07-29ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
42851-060-752022-07-29ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75

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 38 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC507560fe-c7ad-329a-e063-6394a90a039a2026-04-27WarningsExact identifier
application number: M020
SoloVeganHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEYES SALES INC.435748e6-c39a-efee-e063-6294a90ad0e52026-04-27WarningsExact identifier
application number: M020
SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC50764f40-7881-81a3-e063-6294a90ad1cf2026-04-27WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC495bc176-b292-448f-a5a6-00de2e475e542026-04-27WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf45bd7bd-a802-33e4-e053-2a95a90a61a72026-04-23WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERPML NYC, LLC1c2e9b0d-ba0e-1767-e063-6394a90a756c2026-04-23WarningsExact identifier
application number: M020
Skincare LdeL Retinol Day Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATEBeauty Solutions, Ltd.76e2ed34-c643-402b-9c9d-04eac789d3c22026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen Stick SPF 50ZINC OXIDEKenvue Brands LLC4fe1d3c6-7748-d966-e063-6394a90a97ff2026-04-22WarningsExact identifier
application number: M020
OVERLAPS ECTOIN MOIST SUNAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOverlaps Corp.4c3ed60b-e515-8ff0-e063-6294a90a86df2026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacestickZINC OXIDESunny Day Creations50101b55-793e-dbe4-e063-6394a90a61992026-04-22WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%S&C Hampton Sun LLCe6103de6-1d80-46fd-b9d4-893f60941def2026-04-22WarningsExact identifier
application number: M020
PhotoAge GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMACROMOTION, INC.50164bd8-469d-9ec1-e063-6294a90a543d2026-04-22WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Silky Calming Sun StickAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD49947114-5137-dc45-e063-6394a90ad9d02026-04-22WarningsExact identifier
application number: M020
Sky and Sol Intense Healing Lip JellyNON-NANO ZINC OXIDEDelta Ecommerce LLC2ddaa215-7433-c8fa-e063-6394a90a43162026-04-22WarningsExact identifier
application number: M020
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLC0445ee5f-45a8-4fd5-ae4d-62f66e6f0be82026-04-21WarningsExact identifier
application number: M020
BLDG Active Skin Repair Face and Body Performance SunscreenZINC OXIDEInnovacyn, Inc.70cb98cf-739b-4d46-b45a-535ff0a4531c2026-04-21WarningsExact identifier
application number: M020
Freaks of Nature Mineral SunscreenZINC OXIDE MINERAL SUNSCREENEmpack Spraytech Inc.4ffdb1c6-b2c6-628f-e063-6394a90a27692026-04-21WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Water Sun CreamAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD5004126b-0a9c-21fb-e063-6294a90a52372026-04-21WarningsExact 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