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 55 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EWC Slow Lightweight Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEEWC Ventures, LLC063426b8-d1cf-4ee2-8ab8-ff007227eab82026-03-10WarningsExact identifier
application number: M020
Olay Vitamin C Brightening Facial Moisturizer with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4cb268ea-f2b5-ddd1-e063-6394a90a1e962026-03-10WarningsExact identifier
application number: M020
Vacation Grand Cuvee Shimmer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.e0b3d90b-ba56-43e5-aa68-8e5f473628ff2026-03-09WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique ANTHELIOS UVPRO SPORT INVISIBLE SUNSCREEN BROAD SPECTRUM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA, Inc.77f46325-600c-40ff-94fc-ea82d43134c22026-03-09WarningsExact identifier
application number: M020
Civant 50 Sunscreen Broad Spectrum SPF 50OCTOCRYLENE, ZINC OXIDECivant LLCe23622b8-49dd-45b9-8c51-1a83181cc7bd2026-03-09WarningsExact identifier
application number: M020
HydroScreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMETHODIQ INC.4c9d5dfd-d790-fffc-e063-6294a90a4d302026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 45 SunscreenZINC OXIDEShimoda Prime Products, LLC3d48e3e2-18c7-e004-e063-6294a90af4f22026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 30 SunscreenZINC OXIDEShimoda Prime Products, LLC68df620b-7c1c-448c-93fd-91459e393c642026-03-09WarningsExact identifier
application number: M020
EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEADEM, Inc.4ca05e2f-f0c5-821c-e063-6294a90a90b82026-03-09WarningsExact identifier
application number: M020
COOLA SunBlur Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c6439e8-abda-663a-e063-6394a90ac43b2026-03-06WarningsExact identifier
application number: M020
COOLA SunBlur Makeup Mist SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c666a82-293e-06df-e063-6294a90ad5512026-03-06WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4d6d1fda-da78-62ed-e063-6294a90ac1052026-03-06WarningsExact identifier
application number: M020
Palio Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESole Palio LLC071d5113-8fe8-44bb-8322-542eafc2800a2026-03-05WarningsExact identifier
application number: M020
Olay Age Defying Classic Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company4c49dbf1-d1fe-ad4a-e063-6394a90af1512026-03-05WarningsExact identifier
application number: M020
SPF 70 Kids SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aadc378-dc34-9a37-e063-6294a90ad49e2026-03-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.14b9ec0e-6fff-44b1-e063-6394a90aab972026-03-05WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.4c35fbbc-a79d-318f-e063-6394a90a30a72026-03-04WarningsExact identifier
application number: M020
Kids Mineral Sunscreen Stick SPF 50ZINC OXIDESmalls Brand LLC DBA Roe Wellness4c37855b-08c0-0aa7-e063-6394a90a88422026-03-04WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Incbe03b588-afbd-41d1-be96-444d735c97682026-03-03WarningsExact 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