Tinted Mineral Sunscreen 20% Zinc Oxide

Product NDC: 85306-204
11-digit product format: 853060204
Labeler code: 85306
Product ID: 85306-204_458745f8-4e41-ae5d-e063-6394a90ab59f
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: INTEGRATIVE AESTHETICS BOSTON, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-12-12
Substance: ZINC OXIDE
Active strength: 200 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: Tinted Mineral Sunscreen 20% Zinc Oxide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	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
31416d04-2d6f-7cf9-e063-6294a90a9806	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85306-204-60	Tinted Mineral Sunscreen 20% Zinc Oxide	60 g in 1 BOTTLE, PUMP	CREAM	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85306-204	TINTED MINERAL SUNSCREEN 20% ZINC OXIDE (ZINC OXIDE) CREAM [INTEGRATIVE AESTHETICS BOSTON, LLC]	1	Current NDC, 1 package rows	20250328_31416d04-2d6f-7cf9-e063-6294a90a9806.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 69 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Surfers Barrier	ZINC OXIDE	Avasol LLC	d6e2ac0a-3bf6-4d08-8647-6a23de2ac857	2026-01-26	Warnings	Exact identifier application number: M020
SURFERS BARRIER SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Avasol LLC	ec55eef0-17e6-416d-bd5e-548f2f323cea	2026-01-26	Warnings	Exact identifier application number: M020
Zenskin Watery Dew Nia-Cica Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN	Zenskin Co. Ltd.	49584899-d523-9677-e063-6394a90a1403	2026-01-26	Warnings	Exact identifier application number: M020
Caring mill sun serum with Vitamin C Niacinamide	HOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONE	FSA Store lnc.	4931ee71-1088-1ac1-e063-6294a90ad82b	2026-01-25	Warnings	Exact identifier application number: M020
Caring mill Mineral Eye Cream	ZINC OXIDE	FSA STORE INC.	4932ea19-28cc-b245-e063-6394a90ac7aa	2026-01-25	Warnings	Exact identifier application number: M020
Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen	SUNSCREEN 30 MINERAL	LE COSMETICS INC	2cee0413-d532-c192-e063-6294a90aa823	2026-01-25	Warnings	Exact identifier application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Aqua Sunscreen Broad Spectrum SPF 50 plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Jungsaemmool Beauty Co., Ltd.	62e23503-7233-434a-91f0-092f10d2717d	2026-01-24	Warnings	Exact identifier application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Airy Sun Stick Broad Spectrum SPF 50 plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Jungsaemmool Beauty Co., Ltd.	030a20fb-4846-4a5c-9808-a399aac2ff0b	2026-01-24	Warnings	Exact identifier application number: M020
Mimosa Lane SPF45	OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN	R&G Divergency LLC	40f3b8ea-bfa5-4c66-9c79-c4408bda857a	2026-01-24	Warnings	Exact identifier application number: M020
111 SKIN SUNSCREEN SPF 50	ZINC OXIDE	Bentley Laboratories, LLC	b1265797-71dd-4302-ab26-dbff6ccec856	2026-01-23	Warnings	Exact identifier application number: M020
Mania Holic Sunscreen Pack	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Firstmarket Co., ltd.	b95a460c-1f7b-4193-b305-466e073af640	2026-01-23	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 320	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	1cdbae71-441b-426d-99ee-c889d76af452	2026-01-23	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 250	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	8f4b5e0a-4578-4af3-b7d9-a19d4eb732e7	2026-01-23	Warnings	Exact identifier application number: M020
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA	TITANIUM DIOXIDE	LG Household and Healthcare, Inc.	65e70306-9e79-494d-9217-a43002f16307	2026-01-23	Warnings	Exact identifier application number: M020
O HUI Sun Science Ideal Cover Sunscreen Broad Spectrum	TITANIUM DIOXIDE	LG Household and Healthcare, Inc.	c15ffd23-271d-458d-9048-9bc50331d5d7	2026-01-23	Warnings	Exact identifier application number: M020
Aqua protection Sunscreen Broad Spectrum SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ENGLEWOOD LAB, INC.	627e6ea5-016b-4ab6-a50c-aa9c27e5cca1	2026-01-23	Warnings	Exact identifier application number: M020
RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	7fe05ef6-dd5f-4f25-bbf7-24f939642707	2026-01-23	Warnings	Exact identifier application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen Nacre	CEILE SPF 30 PRIME PROTECT RADIATE NACRE	LE COSMETICS INC	4915de09-3a2c-cb75-e063-6394a90a6a57	2026-01-23	Warnings	Exact identifier application number: M020
SPF 50 Sunscreen Stick	ZINC OXIDE	Australian Gold	248d761c-2120-4019-9463-9952bc367e73	2026-01-23	Warnings	Exact identifier application number: M020
SOLBAR THIRTY	SUNSCREEN	Person and Covey	48ed3be8-d146-ec2c-e063-6394a90a6c4d	2026-01-22	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85306-204-21	85306020421	60 g in 1 BOTTLE, PUMP (85306-204-21)	60 g	2024-06-04	No	No	Current
85306-204-60	85306020460	60 g in 1 BOTTLE, PUMP (85306-204-60)	60 g	2023-12-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinted Mineral Sunscreen 20% Zinc Oxide	INTEGRATIVE AESTHETICS BOSTON, LLC \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals LTD	2026-05-21	HUMAN OTC DRUG LABEL	1
Tinted Mineral Sunscreen 20% Zinc Oxide	INTEGRATIVE AESTHETICS BOSTON, LLC \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-12-09	HUMAN OTC DRUG LABEL	2