FDA.reportPublic FDA data

ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45

Product NDC
42851-201
11-digit product format
428510201
Labeler code
42851
Product ID
42851-201_4f81e482-8112-451c-e063-6294a90ad148
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
ZO Skin Health Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-15
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
132; 54 mg/mL; mg/mL
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 Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE132 mg/mL
TITANIUM DIOXIDE54 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f81e482-8111-451c-e063-6294a90ad148Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-201-45ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 451 in 1 CARTONLOTION11
42851-201-45ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 4545 mL in 1 TUBELOTION451

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 23 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Preen Screen Broad Spectrum SPF 50AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.26a0fc0d-a903-2ac1-e063-6394a90a13db2026-06-01WarningsExact identifier
application number: M020
Timesavvy Hybrid XL Cushion Sun Serum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEProBetter USA, Inc.82a22071-f1bd-4fab-b929-8a00ef18f0d92026-05-31WarningsExact identifier
application number: M020
Marine Screen Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEOSEA International, LLC9aa20377-0ab9-4205-b9aa-24640a4641e72026-05-29WarningsExact identifier
application number: M020
Ciele Blush and Protect SugarZINC OXIDECiele LLC52f3a9f6-a226-6723-e063-6394a90a87062026-05-29WarningsExact identifier
application number: M020
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
application number: M020
Daily Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC52f818f4-8485-b228-e063-6294a90a9fe32026-05-29WarningsExact identifier
application number: M020
Dr.G BRIGHT TONING UP TINTED SUNSCREENZINC OXIDE, OCTISALATE, HOMOSALATEGOWOONSESANG COSMETICS CO., LTD.30d34459-b7fb-b0c6-e063-6294a90a08ac2026-05-28WarningsExact identifier
application number: M020
Dr.G GREEN MILD UP DEFENSE MINERAL SUNSCREENZINC OXIDEGOWOONSESANG COSMETICS CO., LTD.30d49f24-3e13-385f-e063-6294a90ab5c82026-05-28WarningsExact identifier
application number: M020
Dr.G R.E.D BLEMISH SOOTHING UP MOISTURE SUNSCREENHOMOSALATE, OCTISALATE, AVOBENZONEGOWOONSESANG COSMETICS CO., LTD.30d53b8a-7e35-0b2b-e063-6294a90aa8df2026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect BerriZINC OXIDECiele LLC52e16cbc-b452-db18-e063-6394a90a40812026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect JuneZINC OXIDECiele LLC52e1c504-f0ee-2853-e063-6394a90a31392026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect JanuaryZINC OXIDECiele LLC52e186df-06aa-6528-e063-6294a90a38882026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect BerriZINC OXIDECiele LLC52e1398d-b170-ea89-e063-6294a90a7d242026-05-28WarningsExact identifier
application number: M020
TIZO ULTRA NON TINTED MINERAL SUNSCREENZINC OXIDE 20%Fallien Cosmeceuticals, LTD30d30610-2e6c-418c-bbcf-4ecd7f61be932026-05-28WarningsExact identifier
application number: M020
Creme FoundationZINC OXIDELauren Brooke Cosmetiques LLC4d09907e-ddcd-9d62-e063-6394a90acf3f2026-05-28WarningsExact identifier
application number: M020
GOONGBE Moisture Sun Cushion Mild SPF 50ZINC OXIDEZero to Seven Inc.1e8720b4-5e8b-dc8b-e063-6394a90aad342026-05-27WarningsExact identifier
application number: M020
GOONGBE Fresh Sun Stick Mild SPF 50ZINC OXIDEZero to Seven Inc.1e8727a4-0dc0-19dc-e063-6394a90a82b62026-05-27WarningsExact identifier
application number: M020
Tallow and Sol SUNSCREEN SPF30NON-NANO ZINC OXIDE 20%Guangzhou Shengyanghui Industrial Trading Co., Ltd52c9dc0a-41f7-3e8a-e063-6394a90a8fca2026-05-27WarningsExact identifier
application number: M020
Tallow and SolSUNSCREEN SPF50NON-NANO ZINC OXIDE 25%Guangzhou Shengyanghui Industrial Trading Co., Ltd52cb56cf-f092-9f86-e063-6394a90ac2d32026-05-27WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen Face and BodyZINC OXIDEToddle Born Wild, Inc.e97d82fe-cd45-43a5-9c1f-3900025240a12026-05-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42851-201-45428510201451 TUBE in 1 CARTON (42851-201-45) / 45 mL in 1 TUBE1 tube2026-04-15NoNoCurrent