Tinted Sunscreen

Product NDC: 85331-203
11-digit product format: 853310203
Labeler code: 85331
Product ID: 85331-203_45af23fa-cc5a-1a7e-e063-6394a90acf71
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Scottsdale Skin Boutique and Dermatology Pllc
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-07-20
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 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
34a52011-b781-75cf-e063-6394a90ae0f4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85331-203-15	Tinted Sunscreen	15 g in 1 PACKET	CREAM	15		2
85331-203-50	Tinted 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
85331-203	TINTED SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC]	1	Current NDC, 1 package rows	20250510_34a52011-b781-75cf-e063-6394a90ae0f4.zip
85331-203	TINTED SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC]	1	Current NDC, 1 package rows	20250510_34a632f5-4458-e335-e063-6394a90a9bcb.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 314 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Deep	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	83725be5-4a0a-4717-a034-ff2999dd4099	2023-12-16	Warnings	Exact identifier application number: M020
Light Day Sunscreen SPF 37	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Circadia by Dr Pugliese, Inc.	16d76785-22a0-4a4b-a6f1-74056612e936	2023-12-15	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME NUDE SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	337a771e-c965-421a-a8e7-d853ffe51c2c	2023-12-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	b4cef09a-f0e4-4054-a200-667df7d150bf	2023-12-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	1f3b56d5-c33a-401f-8c8a-924345a4846e	2023-12-15	Warnings	Exact identifier application number: M020
Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Isagenix International, LLC	6d2d5590-5f53-48d9-94c5-fe9f6a5cf3ce	2023-12-14	Warnings	Exact identifier application number: M020
bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01	TITANIUM DIOXIDE	Orveon Global US LLC	29738578-6681-476e-8660-7219f58e8fa0	2023-12-13	Warnings	Exact identifier application number: M020
Sheer Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Allure Labs	0c6ac094-cb5b-0f09-e063-6394a90a9eed	2023-12-13	Warnings	Exact identifier application number: M020
REDEFINE Triple Defense	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Rodan & Fields	ed0209a6-a8ce-4394-bcf0-32d585a6b834	2023-12-13	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	4e56f3f2-b856-4bbc-ab39-6fb5887a4846	2023-12-13	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2ce83dc2-84b6-43fd-8b11-495d41cebc22	2023-12-13	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca	2023-12-13	Warnings	Exact identifier application number: M020
6000X Elemental Screen BS SPF 30 Sunscreen	ZINC OXIDE	Allure Labs	0c574a9a-edea-d333-e063-6394a90a41e3	2023-12-12	Warnings	Exact identifier application number: M020
RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE	Rodan & Fields	1a936053-2be0-4c52-a073-ba846b87f811	2023-12-12	Warnings	Exact identifier application number: M020
Beet the sun lightweight sunscreen broad spectrum spf 40 pa	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Krave Beauty, LLC	ff93d086-ec80-6bd5-e053-6294a90af019	2023-12-12	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Up The Anti	TITANIUM DIOXIDE, ZINC OXIDE	Biopelle, Inc.	37506766-370e-4ae4-8dbe-915a763e7c55	2023-12-12	Warnings	Exact identifier application number: M020
INTELLIGENT BEAUTY LABS Age Defying Day Broad Spectrum SPF 20	AVOBENZONE, OCTINOXATE, OCTISALATE	DermStore, LLC	19640e0c-c6b3-43b8-91e9-d8d9fff2e44e	2023-12-12	Warnings	Exact identifier application number: M020
Dr. Perrys Day Thyme SPF 20 Broad Spectrum Sunscreen	ZINC OXIDE	Englewood Lab, Inc.	273d8e30-a6bc-4b26-919c-9332fd5197fa	2023-12-12	Warnings	Exact identifier application number: M020
Youth Activating BB SPF30 Shade 3	ZINC OXIDE, TITANIUM DIOXIDE	Englewood Lab, Inc.	c84207c4-a779-4c00-a486-86eaf8ece169	2023-12-12	Warnings	Exact identifier application number: M020
Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	c7526b69-d059-499a-9134-3a1f5d0471b3	2023-12-12	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
85331-203-15	85331020315	15 g in 1 PACKET (85331-203-15)	15 g	2022-07-28	Yes	No	Current
85331-203-50	85331020350	53 g in 1 BOTTLE, PUMP (85331-203-50)	53 g	2022-07-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinted Sunscreen	Scottsdale Skin Boutique and Dermatology Pllc \| Custom Analytics LLC \| Fragrance Manufacturing Inc \| Fallien Cosmeceuticals Ltd.	2025-12-11	HUMAN OTC DRUG LABEL	2
Tinted Sunscreen	Scottsdale Skin Boutique and Dermatology Pllc \| Custom Analytics LLC \| Fragrance Manufacturing Inc \| Fallien Cosmeceuticals Ltd.	2025-12-11	HUMAN OTC DRUG LABEL	2