FDA.reportPublic FDA data

ZO Skin Health Broad-Spectrum Sunscreen SPF 50

Product NDC
42851-064
11-digit product format
428510064
Labeler code
42851
Product ID
42851-064_25a7063a-0d73-c596-e063-6394a90a01a3
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
ZO Skin Health, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
7.552; 17.7 mg/118g; mg/118g
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
ZO Skin Health Broad-Spectrum Sunscreen SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE7.552 mg/118g
ZINC OXIDE17.7 mg/118g

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
d817f80b-a998-b67e-e053-2995a90a1971Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-064-04ZO Skin Health Broad-Spectrum Sunscreen SPF 50118 g in 1 TUBECREAM1184
42851-064-04ZO Skin Health Broad-Spectrum Sunscreen SPF 501 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-064ZO SKIN HEALTH BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ZO SKIN HEALTH, INC.]4Current NDC, Legacy NDC, 2 package rows20241101_d817f80b-a998-b67e-e053-2995a90a1971.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 54 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce63abb-e716-40de-e063-6394a90a6e762026-03-15WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECLIO COSMETICS Co., Ltd.8d147089-709f-4468-a47d-9251e737c9a42026-03-15WarningsExact identifier
application number: M020
Cay Skin Isle Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATECay Skin, Inc.d92a17c4-9827-5fb1-e053-2a95a90a9ca12026-03-13WarningsExact identifier
application number: M020
DAILY FACE SUNSCREEN Broad Spectrum SPF 30ZINC OXIDELilyana Naturals LLCe5f53e2f-6566-4eac-b9b5-7697abaf044b2026-03-13WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLCaf052521-bfa6-4142-a10b-ef51f474a0772026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLC42647444-93a3-4d2c-9bfc-91621fd098f72026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Babies SPF 50AVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLCa4b9d7c0-dc09-4f0e-8b65-90ba180552bf2026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
TINTED WATERY SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEKSISTERS PTE. LTD.4ced53d0-8bfc-ff8e-e063-6294a90a9dbd2026-03-13WarningsExact identifier
application number: M020
Round Lab Birch Juice Mother s Day Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4cf03092-7886-ffa1-e063-6294a90a2aad2026-03-13WarningsExact identifier
application number: M020
Daily Moisturizing Mineral SunscreenBROAD SPECTRUM SPF30EDINA PLASTIC SURGERY,LTD.4d056e2b-5813-da42-e063-6294a90ac5192026-03-13WarningsExact identifier
application number: M020
La Roche Posay Anthelios Sunscreen SPF 60 Ultra lightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEL'Oreal USA, Inc.dad00eee-92cd-7610-e053-2a95a90a1fac2026-03-13WarningsExact identifier
application number: M020
VITARAN REJUVENA SUNCAREALLANTOIN, AVOBENZONE, HOMOSALATE, OCTISALATEBR PHARM CO. , Ltd.4cb7af72-49f6-0738-e063-6394a90a79eb2026-03-12WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 21ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4cd0a8a7-11aa-e168-e063-6394a90a2ff22026-03-12WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEVi-Jon, LLC3da4706e-7c1a-435e-9603-e9aa984320182026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENice-Pak Products, LLC53806657-7b4d-45ff-a75b-9340dcd8140e2026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENice-Pak Products, LLC08237b4c-4e5c-4b12-9510-2f8d64ab7f3a2026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
SunnyDays Broad Spectrum SPF 30 Tinted Sunscreen 5 FairfaxZINC OXIDETower 28108851ac-3812-4c02-a04a-9f9a7f529ed62026-03-12WarningsExact identifier
application number: M020
DIY Booster SPF 30 Facial Serum UnscentedOCTINOXATE, OCTISALATE, AVOBENZONE, AND ZINC OXIDEAndalou naturalsebaf5ef7-84aa-4cb1-a701-2e0d0fd357df2026-03-12WarningsExact identifier
application number: M020
Vacation SPF 50 ClassicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation INC.f268fb1c-d7c2-f2f9-e053-2995a90a9e222026-03-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42851-064-04428510064041 TUBE in 1 CARTON (42851-064-04) / 118 g in 1 TUBE1 tube2022-08-150000-00-00NoNoCurrent