FDA.reportPublic FDA data

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 209 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proven Personalized Day Moisturizer Sunscreen SPF 30ZINC OXIDEProven Skincare5275d2c5-96e8-424d-a3c8-feea778191e42025-06-20WarningsExact identifier
application number: M020
LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR SAf9266687-73d2-dac9-e053-6394a90ac2a12025-06-20WarningsExact identifier
application number: M020
LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEBEL STAR SAfd0465aa-df1e-ce1c-e053-6294a90a23022025-06-20WarningsExact identifier
application number: M020
FEIBTH TALLOW SUNSCREENTALLOW SUNSCREENGuangzhou Qiexiran Cosmetics Co., Ltd.37ead2b1-12d4-af92-e063-6394a90af0d62025-06-19WarningsExact identifier
application number: M020
LipBOMBTITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ef4c1e-2183-a277-e063-6394a90ae2df2025-06-19Exact identifier
application number: M020
Bioresist reinforcing effect face moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR S A99d7525d-b636-7f8e-e053-2a95a90a20802025-06-19WarningsExact identifier
application number: M020
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude TranslucideOCTINOXATE, ZINC OXIDEBEL STAR S Ac4d56723-3953-fb8e-e053-2a95a90a69d32025-06-19WarningsExact identifier
application number: M020
SPF 50 Daily UV Defense Broad Spectrum SunscreenOCTINOXATE, ZINC OXIDEVi Medical Products, INC2d814f8a-23b5-209f-e063-6394a90a50912025-06-19WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f2c5ed-c2f5-e569-e063-6294a90a15b12025-06-19Exact identifier
application number: M020
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude CaramelOCTINOXATE, ZINC OXIDEBEL STAR S Ac4f95c1b-acbe-4bb7-e053-2995a90a91202025-06-19WarningsExact identifier
application number: M020
LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-NOCTINOXATE, ZINC OXIDEBel Star S.A.d22fde8a-ba14-2cc7-e053-2a95a90a0e532025-06-19WarningsExact identifier
application number: M020
Correct and Protect Serum Broad Spectrum SPF 45ZINC OXIDEMurad, LLCdba6e01b-a8ec-4812-bbe0-e418bb0670322025-06-19WarningsExact identifier
application number: M020
Truffoire Truffle BrighteningOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.e3068ecf-0bee-4e8a-a439-4bb707a2845d2025-06-18WarningsExact identifier
application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC383de98b-65b5-4398-a876-87367dc01d0b2025-06-18WarningsExact identifier
application number: M020
CB Multi-Active Moisturizer with SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.d9557a6c-78e9-4b01-8a4b-e0eceb511c4e2025-06-18WarningsExact identifier
application number: M020
1000 Roses CC Color plus Correct Sheer Beige SPF 30ZINC OXIDEAndalou naturals2e7f3570-f710-41dd-95a0-7c0613b317a22025-06-17WarningsExact identifier
application number: M020
Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30TITANIUM DIOXIDE, ZINC OXIDESKIN CARE BY SCOTTIE LLCa9afa58c-f438-48c6-bd30-eda41334df742025-06-16WarningsExact identifier
application number: M020
Wellage Real Hyaluronic Watery Glow Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHugel, Inc.37aa2f7b-afa4-5cc9-e063-6294a90ae7412025-06-16WarningsExact identifier
application number: M020
Dermaka Sunscreen SPF 42, TintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9a967cd1-9eec-4255-b14b-ac2e33e4dbf02025-06-16WarningsExact identifier
application number: M020
Elizabeth Arden Eight Hour Hydraplay SPF 40OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENERevlon Consumer Products Corp2cc74177-0f62-106e-e063-6394a90a6e282025-06-16WarningsExact 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