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 17 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
application number: M020
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
application number: M020
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink Pineapple SunriseAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c30a422-b22a-ca79-e063-6294a90a19a92026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink Pineapple SunriseAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c37a994-79dd-9720-e063-6294a90a7f342026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Waikiki Beach CoconutAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c37b8d7-de72-f534-e063-6294a90aeab72026-06-26WarningsExact identifier
application number: M020
UV Daily Hydration TintedOCTISALAT AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc02e71602-13e1-43b3-9cba-a75e46cccacc2026-06-25WarningsExact identifier
application number: M020
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6759b9f7-296a-4c06-9198-b4e824e0bdc92026-06-25WarningsExact identifier
application number: M020
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
application number: M020
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
application number: M020
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
application number: M020
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
application number: M020
Scalp and Face Sunscreen Broad Spectrum SPF 30ZINC OXIDEOnly Balds LLC551bf10e-598c-1400-e063-6294a90a4af12026-06-25WarningsExact identifier
application number: M020
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
application number: M020
MORANDIPARK PANTHENOL ULTRA LIGHT SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBRAND GENOME CO., Ltd.51c07375-e81d-8572-e063-6394a90ab5b02026-06-24WarningsExact identifier
application number: M020
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC365613b6-36ec-0512-e063-6294a90a95322026-06-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC235a9430-b445-8d5c-e063-6394a90a93542026-06-24WarningsExact identifier
application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact 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