Sunscreen Cream

Product NDC: 84938-007
11-digit product format: 849380007
Labeler code: 84938
Product ID: 84938-007_460f0ca0-9441-9a6e-e063-6394a90a33b3
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide 12%,Titanium Dioxide 8%, Homosalate 12%, Octisalate4.5%,Phenylbenzimidazole Sulfonic Acid 3.5%
Dosage form: CREAM
Route: TOPICAL
Labeler: Foshan Sugar Max Cosmetics CO.,Ltd
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-12-16
Substance: PHENYLBENZIMIDAZOLE SULFONIC ACID; ZINC OXIDE; TITANIUM DIOXIDE; HOMOSALATE; OCTISALATE
Active strength: .035; .12; .08; .12; .045 g/mL; g/mL; g/mL; g/mL; g/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Sunscreen Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLBENZIMIDAZOLE SULFONIC ACID	.035 g/mL
ZINC OXIDE	.12 g/mL
TITANIUM DIOXIDE	.08 g/mL
HOMOSALATE	.12 g/mL
OCTISALATE	.045 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9YQ9DI1W42	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	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
460f0ca0-9440-9a6e-e063-6394a90a33b3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84938-007-01	Sunscreen Cream	90 mL in 1 BOTTLE	CREAM	90		1

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 138 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SHADED	TITANIUM DIOXIDE, ZINC OXIDE	Potency No. 710 LLC	3117e138-83a1-0931-e063-6394a90abe43	2025-12-10	Warnings	Exact identifier application number: M020
SHADED	TITANIUM DIOXIDE, ZINC OXIDE	Potency No. 710 LLC	31188175-a4ca-449f-e063-6394a90a3c05	2025-12-10	Warnings	Exact identifier application number: M020
COVERED	ZINC OXIDE	Potency No. 710 LLC	3118c3ed-f0f0-f997-e063-6294a90a53a9	2025-12-10	Warnings	Exact identifier application number: M020
COVERED	ZINC OXIDE	Potency No. 710 LLC	3117faeb-1792-1b2e-e063-6294a90a92df	2025-12-10	Warnings	Exact identifier application number: M020
Non-Tinted Mineral Foaming Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Restore Skin Therapy, LLC	364b6af2-a0ed-4a17-e063-6394a90a3a17	2025-12-10		Exact identifier application number: M020
Morning Replenish	ZINC OXIDE	Restore Skin Therapy, LLC	364b26c2-a1bb-9660-e063-6294a90a14d1	2025-12-10		Exact identifier application number: M020
Glass Skin Sunscreen Tinted	ZINC OXIDE	Fleur de Lune, LLC	34288989-35b8-3aa3-e063-6394a90ac2c4	2025-12-10		Exact identifier application number: M020
Glass Skin Sunscreen Tinted	ZINC OXIDE	Fleur de Lune, LLC	3418394b-fede-65ce-e063-6394a90ad5f9	2025-12-10		Exact identifier application number: M020
Glass Skin Sunscreen Non-Tinted	ZINC OXIDE	Fleur de Lune, LLC	341871e5-c170-7560-e063-6394a90a8eee	2025-12-10		Exact identifier application number: M020
Glass Skin Sunscreen Non-Tinted	ZINC OXIDE	Fleur de Lune, LLC	3428bdbb-1f18-a29b-e063-6294a90addbc	2025-12-10		Exact identifier application number: M020
Sheer Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342b2403-4f4a-3e77-e063-6294a90a4f0a	2025-12-10		Exact identifier application number: M020
Sheer Mineral Sunscreen Bar	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342b69d5-f0e1-99cd-e063-6294a90abb6e	2025-12-10		Exact identifier application number: M020
Sheer Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342c3f42-c17f-f777-e063-6394a90a8058	2025-12-10		Exact identifier application number: M020
Lip SPF	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396d3fdd-99d8-77e8-e063-6294a90aec2f	2025-12-10		Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396cae82-7641-e1b2-e063-6394a90a7c07	2025-12-10		Exact identifier application number: M020
Solar Knight SPF 40 Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	MASCARENAS ENTERPRISES, INC.	36c27c91-22ac-205c-e063-6294a90ab379	2025-12-10		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396ce15a-06ad-4055-e063-6294a90a27fb	2025-12-10		Exact identifier application number: M020
Dermablue Daily Replenishing	ZINC OXIDE	Dermablue, P.C.	308da9c9-544e-d5d1-e063-6294a90aa49b	2025-12-10	Warnings	Exact identifier application number: M020
Recoverie Mineral Matte	ZINC OXIDE	Clear Day Acne Clinic	308f41de-fb14-40f9-e063-6394a90a008f	2025-12-10	Warnings	Exact identifier application number: M020
AL0043600 Alba Botanica VE Herbal Healing Body	COLLOIDAL OATMEAL	The Hain Celestial Group, Inc.	60672feb-141f-651e-e053-2a91aa0af41d	2025-12-10	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
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84938-007-01	84938000701	90 mL in 1 BOTTLE (84938-007-01)	90 ml	2025-12-16	No	No	Current