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: 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: Untinted Sheer Defense
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	38 mg/g
TITANIUM DIOXIDE	80 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
35be50b7-a9af-29ee-e063-6394a90a45ba	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85516-202-50	Untinted Sheer Defense	53 g in 1 BOTTLE, PUMP	CREAM	53		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85516-202	UNTINTED SHEER DEFENSE (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [KRISTINA LERNER]	1	Current NDC, 1 package rows	20250524_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 280 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Market Basket Continuous Sunscreen General Protection SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	DEMOULAS SUPER MARKETS, INC.	e7182d07-a006-db4b-e053-2995a90aa9e1	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	e467df80-9007-46c9-e053-2a95a90a1bef	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT KIDS SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	e467c306-a2ed-4976-e053-2995a90a56ed	2024-10-17	Warnings	Exact identifier application number: M020
Exchange Select Sport Sunscreen Continuous SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	Army & Air Force Exchange Service	e716ba8c-0148-07f2-e053-2a95a90a53df	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	f55828b4-f2a4-13ec-e053-2995a90a0f84	2024-10-17	Warnings	Exact identifier application number: M020
SPF50 Plus Mineral Sunscreen	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	08e8bc10-85d8-4215-8351-7ec12029416c	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	9ac92c96-5bcf-421d-9cd0-73ddfa10195c	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	20b32aae-7f8b-44ed-a3df-706054fd6883	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	d77be4d0-c08a-4d81-b5df-a9bae38e3b97	2024-10-17	Warnings	Exact identifier application number: M020
FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN	HOMOSALATE, OCTISALATE	FRUIT OF THE EARTH, INC.	13325a2a-f7f8-4019-acbb-205fd5dd13a5	2024-10-17	Warnings	Exact identifier application number: M020
FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	ae7951e9-54f6-4eab-81b6-a2b2c978851d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Clubwith Blood Orange and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7805f3c-5b95-73bd-e053-2a95a90a9984	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Manuka Honey and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7820ba9-7520-5139-e053-2a95a90ab92d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Blood Orange and Essential Oils SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7916317-c6a2-2eda-e053-2995a90a1628	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Mentha and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c790031d-5448-a998-e053-2a95a90a763e	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of The Earth Sun Town City Kids SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c79472ea-a367-1328-e053-2a95a90a22d5	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Dark Tanning Dry Oil SPF 8 Sunscreen	HOMOSALATE, OCTISALATE	Fruit of the Earth, Inc.	c7a94f68-a4d5-ec82-e053-2995a90a38fb	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7ba72c2-ea23-0bb9-e053-2a95a90a1d90	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c795cd2f-89dc-78e3-e053-2a95a90a9422	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7a4783f-477f-1524-e053-2995a90a5ad9	2024-10-17	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85516-202-50	85516020250	53 g in 1 BOTTLE, PUMP (85516-202-50)	53 g	2025-05-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Untinted Sheer Defense	Kristina Lerner \| Custom Analytics LLC \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2