Untinted Sheer Defense

Product NDC
85516-202
11-digit product format
855160202
Labeler code
85516
Product ID
85516-202_46042d20-dc41-fe77-e063-6394a90a94aa
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Kristina Lerner
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-05
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
38; 80 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Untinted Sheer Defense
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE38 mg/g
TITANIUM DIOXIDE80 mg/g

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
35be50b7-a9af-29ee-e063-6394a90a45baAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85516-202-50Untinted Sheer Defense53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85516-202UNTINTED SHEER DEFENSE (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [KRISTINA LERNER]1Current NDC, 1 package rows20250524_35be50b7-a9af-29ee-e063-6394a90a45ba.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 174 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Expedition BackCountry SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.06c1ac52-474c-db5c-e063-6294a90afb5f2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30 Tinted ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d1287899-f178-6124-e053-2a95a90a95a52025-11-04WarningsExact identifier
application number: M020
Naked Sundays BeautyScreen Peptide Foundation TintZINC OXIDENaked Sundays1a623dfc-a8fc-858b-e063-6294a90a9c112025-11-04WarningsExact identifier
application number: M020
Odacite Mineral Drops Sheer SunscreenZINC OXIDEOdacite303f3af6-631a-57a8-e063-6294a90addda2025-11-04WarningsExact identifier
application number: M020
MedlineZINC OXIDEMedline Industries, LPcadba3bc-4a06-872a-e053-2995a90ab4472025-11-04WarningsExact identifier
application number: M020
Perricone MD Hypoallergenic CBD Sensitive Skin Therapy Ultra-Lightweight Calming SPF 35 VeilZINC OXIDETHG Beauty USA LLC2392c772-c251-1597-e063-6394a90a52f22025-11-03WarningsExact identifier
application number: M020
Hawaiian Tropic everyday Active Sport Sunscreen SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care LLCdc7d0757-c8a2-7fdb-e053-2a95a90a52822025-11-03WarningsExact identifier
application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant (80min) Mineral Sunscreen LIGHTTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesa7f906f6-3041-4c24-955d-90cdd402dd022025-11-03WarningsExact identifier
application number: M020
Biopo Facial Mineral Sunscreen-Non Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN-NON TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bc865f-29bd-da90-e063-6294a90aa16d2025-11-03WarningsExact identifier
application number: M020
Biopo Facial Mineral Sunscreen- Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN- TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bd8bce-2959-266a-e063-6394a90a9a412025-11-03WarningsExact identifier
application number: M020
GoodSense SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inc.c23c754a-9441-0a05-e053-2995a90afc552025-11-02WarningsExact identifier
application number: M020
SPF 30 Sport Sunscreen GoodSenseAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Geiss, Destin, & Dunn, Inca22c6359-435d-626b-e053-2a95a90ae0c62025-11-02WarningsExact identifier
application number: M020
Iris and Romeo Weekend SkinZINC OXIDEIris and Romeo0828a345-0178-1503-e063-6394a90a7d242025-10-31WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Bronze GlowZINC OXIDEIris and Romeo2abe1780-d1e6-a90a-e063-6294a90a64ee2025-10-31WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Warm GlowZINC OXIDEIris and Romeo0852977a-83e5-26cf-e063-6294a90ab3f92025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Light 205 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.055878ef-c671-4d65-9639-bda5a1dc30292025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Fair 120 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b6b18a13-1f22-4061-91f5-852f7a487c032025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Fair 100 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.d7815651-6b14-41f6-90cd-0a5b0b4a12ac2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Fair 140 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.59331429-5fe0-4671-aabd-ec20640dd3ee2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Fair 125 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.c6ef3b07-babf-401d-a241-4e81e162c9652025-10-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85516-202-508551602025053 g in 1 BOTTLE, PUMP (85516-202-50) 53 g2025-05-05NoNoCurrent