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 285 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Broad Spectrum SPF 40 Radiant Facial Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24114416-33b9-c6ba-e063-6394a90a6f3b	2024-10-09	Warnings	Exact identifier application number: M020
Walgreens 40 Invisible Facial Sunscreen Broad Spectrum SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	0c40a46b-b9f9-8e14-e063-6394a90a9573	2024-10-09	Warnings	Exact identifier application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102	ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE	AMOREPACIFIC CORPORATION	531f60c9-c89a-46bc-8460-d01b2e838e6f	2024-10-08	Warnings	Exact identifier application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	AMOREPACIFIC CORPORATION	60964d9f-d96c-4397-b273-6b63d1886722	2024-10-08	Warnings	Exact identifier application number: M020
IOPE AIR CUSHION Cover 21 Vanilla	ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE	AMOREPACIFIC CORPORATION	29d6cc8d-1469-479d-a15a-e78d4e22d4a2	2024-10-08	Warnings	Exact identifier application number: M020
IOPE UV DEFENSE SUN PROTECTOR	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	AMOREPACIFIC CORPORATION	0f2a87f7-2185-16a5-e063-6294a90a92a3	2024-10-08	Warnings	Exact identifier application number: M020
Tropical Topical Matte SPF30	ZINC OXIDE	Allure Labs	039fba4b-720a-9199-e063-6394a90adbfb	2024-10-08	Warnings	Exact identifier application number: M020
LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	AMOREPACIFIC CORPORATION	0e746836-ed84-7b33-e063-6294a90aeff3	2024-10-08	Warnings	Exact identifier application number: M020
DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen	AVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE	PureTek Corporation	86eb06cc-d63f-4500-a52e-14ef99a56532	2024-10-02	Warnings	Exact identifier application number: M020
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a	2024-10-01	Warnings	Exact identifier application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen	ZINC OXIDE	Fallien Cosmeceuticals, LTD	231af290-99ee-e94d-e063-6394a90a0bef	2024-09-27	Warnings	Exact identifier application number: M020
Target Up and Up SPF 70 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	23085ab9-5abb-a572-e063-6394a90ae34a	2024-09-26	Warnings	Exact identifier application number: M020
Target Up and Up Morning Facial Moisturizing with SPF 30 Sunscreen and Ceramides	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	TARGET CORPORATION	23598ad1-12a3-fe65-e063-6394a90a4f6f	2024-09-26	Warnings	Exact identifier application number: M020
Target Up and Up SPF 30 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	22f59a88-02d7-ebdb-e063-6394a90a957b	2024-09-25	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen Stick	ZINC OXIDE	TARGET CORPORATION	22f7c376-7289-04bf-e063-6394a90a1459	2024-09-25	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	TARGET CORPORATION	22f86630-d4b4-8ad7-e063-6394a90a8d1e	2024-09-25	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	TARGET CORPORATION	22f9044a-f54c-b34b-e063-6394a90a88ee	2024-09-25	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE ,OCTOCRYLENE	Edgewell Personal Care Brands LLC	22e2b447-bd6b-5e8a-e063-6394a90a0de9	2024-09-24	Warnings	Exact identifier application number: M020
Luminous Defense SPF 50	ZINC OXIDE	Levels 2 Skin	22e177b3-beea-212e-e063-6394a90a1452	2024-09-24	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	22e359cd-4c63-b124-e063-6394a90aec73	2024-09-24	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