Tinted Facial Mineral Sunscreen SPF 40

Product NDC: 85508-203
11-digit product format: 855080203
Labeler code: 85508
Product ID: 85508-203_45c70020-8290-d6dd-e063-6394a90a8433
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: RSL89 LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-02-28
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: Tinted Facial Mineral Sunscreen SPF 40
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
3531d609-a0d8-cb59-e063-6394a90a4bea	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85508-203-15	Tinted Facial Mineral Sunscreen SPF 40	1.5 g in 1 PACKET	CREAM	1.5		2
85508-203-50	Tinted Facial Mineral Sunscreen SPF 40	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
85508-203	TINTED FACIAL MINERAL SUNSCREEN SPF 40 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [RSL89 LLC]	1	Current NDC, 1 package rows	20250519_3531d609-a0d8-cb59-e063-6394a90a4bea.zip
85508-203	TINTED FACIAL MINERAL SUNSCREEN SPF 40 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [RSL89 LLC]	1	Current NDC, 1 package rows	20250519_3532a6a2-dbb5-8111-e063-6294a90aeaeb.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 316 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting Shade	TITANIUM DIOXIDE, ZINC OXIDE	Boscia LLC	5169b10e-5a8d-479a-a6a8-1e7a13cb70c4	2023-12-12	Warnings	Exact identifier application number: M020
Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20	TITANIUM DIOXIDE	Boscia LLC	f76166f1-e987-4eaf-8192-14dc08c481f7	2023-12-12	Warnings	Exact identifier application number: M020
Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PA	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Boscia LLC	2a6b507f-0967-46e1-8360-0003772f1bdb	2023-12-12	Warnings	Exact identifier application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Oily Skin	OCTINOXATE, OCTISALATE, ZINC OXIDE	Likewise Incorporated	97bd2033-2cf0-4e5d-81e2-c453a1e3a65e	2023-12-12	Warnings	Exact identifier application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 01	TITANIUM DIOXIDE	3LAB, Inc.	703dc828-24b4-4f04-9f2c-4a2edfdf4632	2023-12-12	Warnings	Exact identifier application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 02	TITANIUM DIOXIDE	3LAB, Inc.	7c6c7062-91f7-4304-98c3-f77967a2d329	2023-12-12	Warnings	Exact identifier application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Dry Skin	OCTINOXATE, OCTISALATE, ZINC OXIDE	Likewise Incorporated	8a75dde9-8dcb-4f4a-b9df-88338bd2a440	2023-12-12	Warnings	Exact identifier application number: M020
Everyday Facial Moisturizer And Sunscreen SPF 20	ZINC OXIDE	714 Essentials LTD	3a29018b-8103-4983-b0c5-5f340775a05d	2023-12-12	Warnings	Exact identifier application number: M020
Likewise Hand Moisturizer - Sun Protectant SPF 50	OCTINOXATE, OCTISALATE, ZINC OXIDE	Likewise Incorporated	a54f0854-c55e-4a46-9084-16cb1be0f681	2023-12-12	Warnings	Exact identifier application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 01	TITANIUM DIOXIDE	3LAB, Inc	bd39d2fb-8326-4e19-b634-7a7308313d8a	2023-12-12	Warnings	Exact identifier application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 03	TITANIUM DIOXIDE	3LAB, Inc	19884289-edb2-4d18-bd62-873533b94a10	2023-12-12	Warnings	Exact identifier application number: M020
Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	92dc1a86-590e-4144-9d30-172645e63140	2023-12-12	Warnings	Exact identifier application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 02	TITANIUM DIOXIDE	3LAB, Inc	bf4419b9-408d-469a-aa15-bbf419632f02	2023-12-12	Warnings	Exact identifier application number: M020
3LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	3LAB, Inc	2bee6b87-c889-4ea1-87ad-e28949bcb67a	2023-12-12	Warnings	Exact identifier application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily Skin	TITANIUM DIOXIDE, ZINC OXIDE	Likewise Incorporated	28b8c519-8417-427e-8d4f-94da44a69d9f	2023-12-12	Warnings	Exact identifier application number: M020
BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PA	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ENGLEWOOD LAB, INC.	f5c795f0-63bc-3033-e053-2995a90a55ab	2023-12-12	Warnings	Exact identifier application number: M020
Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	c06ecc56-2044-4396-8acd-6d18af9b984c	2023-12-12	Warnings	Exact identifier application number: M020
SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	f5c7b7ce-b3ed-3e96-e053-2995a90a8ea9	2023-12-12	Warnings	Exact identifier application number: M020
Milani SPF BFF 30 Primer	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE	New Milani Group, LLC	c7a1f2a7-d299-2116-e053-2995a90ad8c5	2023-12-12	Warnings	Exact identifier application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	New Milani Group, LLC	8f52f614-1cfe-4ef0-8cb6-37afbfddf44c	2023-12-12	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
85508-203-15	85508020315	1.5 g in 1 PACKET (85508-203-15)	1.5 g	2023-07-06	Yes	No	Current
85508-203-50	85508020350	53 g in 1 BOTTLE, PUMP (85508-203-50)	53 g	2023-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinted Facial Mineral Sunscreen SPF 40	RSL89 LLC \| Custom Analytics LLC \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-12	HUMAN OTC DRUG LABEL	2
Tinted Facial Mineral Sunscreen SPF 40	RSL89 LLC \| Custom Analytics LLC \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-12	HUMAN OTC DRUG LABEL	2