FDA.reportPublic FDA data

ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light Medium)

Product NDC
42851-212
11-digit product format
428510212
Labeler code
42851
Product ID
42851-212_5ce2510c-a7b2-069f-e063-6394a90a7e10
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 50 (Light Medium)
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

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

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 14 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOING COCONUTSZINC OXIDECOSMAX USA, CORP564b5ab3-0a7c-f663-e063-6394a90a0c3d2026-07-10WarningsExact identifier
application number: M020
UV RESTORE FACE SERUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA564b8070-ee59-0c24-e063-6294a90ad9a92026-07-10WarningsExact identifier
application number: M020
COCO-EVE COCONUT MILK BODY SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA564b80c2-16e0-fb5f-e063-6394a90a50d22026-07-10WarningsExact identifier
application number: M020
COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECOSMAX USA564b9b1f-3d5b-4349-e063-6294a90a3b772026-07-10WarningsExact identifier
application number: M020
NORWEX Lip Glaze Broad Spectrum SPF 30 HazelnutZINC OXIDECOSMAX USA564ba912-c44b-4940-e063-6294a90a28fa2026-07-10WarningsExact identifier
application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA564bbb5f-4000-390d-e063-6294a90a408d2026-07-10WarningsExact identifier
application number: M020
PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30ZINC OXIDECOSMAX USA564bb5f9-5ac5-548b-e063-6394a90a84622026-07-10WarningsExact identifier
application number: M020
ILLUSION LUMINOUS GLOW FOUNDATIONAVOBENZONE, HOMOSALATE, AND OCTISALATEKingdom Animalia, LLC DBA Hourglass Cosmeticscf6a7e1a-7bca-439c-808a-80262f095f842026-07-10WarningsExact identifier
application number: M020
Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEThe Procter & Gamble Manufacturing Company30a063fa-e537-a2c1-e063-6394a90a6a832026-07-09WarningsExact identifier
application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 SensitiveOCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company3cb971e1-34f1-ee89-e063-6394a90a52a92026-07-09WarningsExact identifier
application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company3cb9de81-f05e-9697-e063-6394a90a69c52026-07-09WarningsExact identifier
application number: M020
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
application number: M020
Sunny C Sunscreen SPF 50SUNNY C SUNSCREENMIXIK, INC.4ed2a482-6c63-69f5-e063-6394a90ad3ee2026-07-08WarningsExact identifier
application number: M020
Ultra Violette Supreme Screen Broad Spectrum SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.24389324-19db-7eb5-e063-6394a90ad7fb2026-07-08WarningsExact identifier
application number: M020
ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONECOSMAX USA, CORPORATION562053d4-12bd-976e-e063-6394a90a59de2026-07-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
application number: M020
Sun Protection Mineral SPF 30ZINC OXIDEderma ebf6474a7-a21f-49cb-86e6-e5c40dbd34c32026-07-08WarningsExact identifier
application number: M020
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink DreamAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.560785f5-9126-12ba-e063-6294a90ac9462026-07-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42851-212-45428510212451 TUBE in 1 CARTON (42851-212-45) / 45 mL in 1 TUBE1 tube2026-04-15NoNoCurrent