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 74 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANUA INVISIBLE MATTE FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.4248deaf-ad55-a9b4-e063-6294a90a55cc2026-01-19WarningsExact identifier
application number: M020
ONSART Mineral SunscreenZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.48c9d08d-9a91-7df5-e063-6294a90a1c4a2026-01-19WarningsExact identifier
application number: M020
Intense Moisture Day CreamAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENECVS Health795d3546-f0dd-4b54-9807-9cdb3e6261812026-01-19WarningsExact identifier
application number: M020
CURESHIELD MANICURE SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD48b4fad7-073d-d983-e063-6394a90ae3142026-01-18WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65ff0448-17e6-42ce-989a-940794fcbd8c2026-01-17WarningsExact identifier
application number: M020
BenzoAzeline 10BENZOYL PEROXIDENoon Aesthetics M.R. Ltd985efa19-bd91-45cd-a2a0-d71ec325e51c2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Berry SPF 30PREQUEL LIP VISOR BERRY SPF 30The Center Brands, LLCe4f3a0eb-4a8c-4145-92e4-979f03e3a5112026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Blush SPF 30PREQUEL LIP VISOR BLUSH SPF 30The Center Brands, LLCbc681245-e158-4cfa-9718-7ec4cff0e60d2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Mahogany SPF 30PREQUEL LIP VISOR MAHOGANY SPF 30The Center Brands, LLCea8dcd14-3c54-46a6-aabc-3655f051065b2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Nude SPF 30PREQUEL LIP VISOR NUDE SPF 30The Center Brands, LLC03a7c77d-7b6e-4720-88f1-492ce57c71452026-01-16WarningsExact identifier
application number: M020
Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30ZINC OXIDECVL Cosmetics North America Incf3057856-1461-41d3-a5c4-9f12e3a4a0ee2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior04e9c4d8-1600-4ffc-8578-4ffb82b106f32026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1aae19da-1e73-41ed-91dc-0746ad311b872026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior22d4452d-3798-48c6-a7a4-4af0f99b4ebd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord6800bb7-16ef-48f6-a09a-0422e64ad8bd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorfb9cfd4f-a558-4df2-bbbf-b814ae19a1352026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9ddcda6-3d87-4197-a2c2-5b30016d32eb2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior25abef37-1726-491f-8a11-ac1a96378ed12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb0e315b3-a322-4607-b212-bcadd5aa99bc2026-01-16WarningsExact 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