Tinted Mineral Sunscreen

Product NDC: 85327-203
11-digit product format: 853270203
Labeler code: 85327
Product ID: 85327-203_458a488b-636b-ac69-e063-6294a90a9b0f
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Rhonda J Pomerantz MD PLLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-12-15
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 80; 38 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: Tinted Mineral Sunscreen
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
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
325c3a18-ba8f-912d-e063-6394a90a2447	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85327-203-15	Tinted Mineral Sunscreen	1.5 g in 1 PACKET	CREAM	1.5		2
85327-203-50	Tinted Mineral Sunscreen	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
85327-203	TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [RHONDA J POMERANTZ MD PLLC]	1	Current NDC, 1 package rows	20250410_325c3a18-ba8f-912d-e063-6394a90a2447.zip
85327-203	TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [RHONDA J POMERANTZ MD PLLC]	1	Current NDC, 1 package rows	20250410_325c8641-1161-b8ac-e063-6394a90ae451.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 187 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Blueberry Nutri Tint SPF 20 15N Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	8d76a963-bdf5-44a1-b1d6-27d1a3aaa1ae	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 16N Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	d279693f-2254-4f3c-a121-144f95f9f25d	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 12N Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	7f007540-8271-4d85-9d1e-b2b273ca05f8	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 17W Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	5198d3df-ffa8-45eb-93d1-11e9f3961b92	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 18N Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	a82d85c4-c6ef-4083-b67a-2d6b0e8fc10d	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 19W Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	4ee6cac6-f649-436c-ada2-e024b86add69	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 24N Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	edd4e8c3-b47a-4cfe-bf20-e856edb76e21	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 21W Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	457f0a5c-c543-44f8-82d6-1096a8aab984	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 22N Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	1452ffc4-a83f-472f-ae70-9e1002f88945	2025-09-08	Warnings	Exact identifier application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen Scent of Sunshine	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GNL BRANDS INTERNATIONAL, LLC	3e518d8a-f52b-4ae1-e063-6394a90aaa1e	2025-09-08	Warnings	Exact identifier application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GNL BRANDS INTERNATIONAL, LLC	3c5a624a-8844-b782-e063-6294a90a478c	2025-09-08	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5	ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3dbb07e2-971c-284d-e063-6294a90a437f	2025-09-06	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6	ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3e069cb2-c4c5-abf5-e063-6394a90a56b0	2025-09-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 2C Light	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	761ce50c-2bf5-4ed0-91ac-9c47f8790ddb	2025-09-05	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 3W Light	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	2781b921-eb0d-4270-addf-47301577b28c	2025-09-05	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 5N Light	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	893434a1-72b8-4f0f-bfaa-2c9d775d7e27	2025-09-05	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 7N Light	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	199d97a2-d32b-45ab-a43d-30522b0ca596	2025-09-05	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 10N Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	638eafb5-08a8-425f-893f-d6609b868e2b	2025-09-05	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 9C Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	41fd80a9-2c6f-4f3e-a37d-e781965ddc55	2025-09-05	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 11W Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	50bac9fb-5b81-4cdd-9eae-ec9530fc46c3	2025-09-05	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
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
85327-203-15	85327020315	1.5 g in 1 PACKET (85327-203-15)	1.5 g	2021-12-15	Yes	No	Current
85327-203-50	85327020350	53 g in 1 BOTTLE, PUMP (85327-203-50)	53 g	2021-12-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinted Mineral Sunscreen	Rhonda J Pomerantz MD PLLC \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-12-09	HUMAN OTC DRUG LABEL	2
Tinted Mineral Sunscreen	Rhonda J Pomerantz MD PLLC \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-12-09	HUMAN OTC DRUG LABEL	2