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 205 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Counter Beauty Dew Skin Tinted Moisturizer No. 3ZINC OXIDEG2G Ventures, PBC3a35bbb2-a1eb-346b-e063-6294a90a90782025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 4ZINC OXIDEG2G Ventures, PBC3a35f23b-3732-db3c-e063-6294a90ae00c2025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 5ZINC OXIDEG2G Ventures, PBC3a35fd79-f4d3-5ccf-e063-6294a90a97982025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 6ZINC OXIDEG2G Ventures, PBC3a360053-5863-95fe-e063-6394a90a45c52025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 8ZINC OXIDEG2G Ventures, PBC3a362e05-3a1e-8059-e063-6294a90ad5252025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 7ZINC OXIDEG2G Ventures, PBC3a3621c2-709a-82fd-e063-6294a90a7a7e2025-07-18WarningsExact identifier
application number: M020
Basin Pina Colada SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc3a39ac31-85c9-5e04-e063-6394a90aa5372025-07-18WarningsExact identifier
application number: M020
Basin American Pink Lemonade SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3afeda-f235-eac2-e063-6294a90a5a932025-07-18WarningsExact identifier
application number: M020
Basin Chinese Mandarin SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3b5f56-aa36-01c7-e063-6294a90a6d622025-07-18WarningsExact identifier
application number: M020
Counter Beauty Daily Sheer Defense SPF 25ZINC OXIDEG2G Ventures, PBC3a22d88b-cdb5-5656-e063-6294a90a5b772025-07-17WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 1ZINC OXIDEG2G Ventures, PBC3a2676ed-087d-f957-e063-6294a90ad4572025-07-17WarningsExact identifier
application number: M020
Sjolie Tanning SPF 30 SunscreenZINC OXIDESJOLIE, INC.3a283a09-2edb-f92c-e063-6294a90a82bd2025-07-17WarningsExact identifier
application number: M020
Neutrogena Clear Body Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC32889c1e-d539-4b36-b012-9789c4a8d6422025-07-16WarningsExact identifier
application number: M020
GZE Tinted SunscreenZINC OXIDE 3%Guangzhou Yilong Cosmetics Co.,Ltd.182612d8-76a4-44a1-e063-6394a90a8d5f2025-07-15WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC089b798b-829f-aa86-e063-6294a90a86312025-07-15WarningsExact identifier
application number: M020
MO HANDSOME Protection Sport Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENE8 PINE DESIGN LLC982ada30-5f87-42c6-b9ea-fedd842aa09d2025-07-15WarningsExact identifier
application number: M020
Amarte ULTRA VEIL DailySUNSCREENAmarte USA LLC39e9ca98-d0e8-6b8f-e063-6394a90aa3662025-07-15WarningsExact identifier
application number: M020
Amarte ULTRA VEIL BB FairSUNSCREENAmarte USA LLC39e87950-4103-c2eb-e063-6394a90a05522025-07-15WarningsExact identifier
application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUNSTICKAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEDONGDONGGURIMOO CO.,LTD.39eea41c-8703-cf1f-e063-6394a90a5b1f2025-07-14WarningsExact identifier
application number: M020
Basin Vanilla SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.4a8e7be0-97a6-ada5-e063-6294a90ae25a2025-07-14WarningsExact 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