FDA.reportPublic FDA data

Equate

Product NDC
49035-753
11-digit product format
490350753
Labeler code
49035
Product ID
49035-753_249e8989-e84a-2bf4-e063-6394a90a5cf0
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Wal-Mart Stores Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-12
Substance
ZINC OXIDE; OCTOCRYLENE
Active strength
50.2125; 40 mg/mL; mg/mL
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
Equate
Brand name suffix
SPF 50 Ultra Zinc Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE50.2125 mg/mL
OCTOCRYLENE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8fdc0bad-8834-5b4a-e053-2a95a90a9fdeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-753-42EquateSPF 50 Ultra Zinc Sunscreen29.6 mL in 1 JARLOTION29.64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-753EQUATE SPF 50 ULTRA ZINC SUNSCREEN (OCTOCRYLENE, ZINC OXIDE) LOTION [WAL-MART STORES INC]4Current NDC, Legacy NDC, 1 package rows20241018_8fdc0bad-8834-5b4a-e053-2a95a90a9fde.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 175 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
luminous aqua sunscreen mistAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd29fc0c2b-8d10-8704-e063-6394a90ad5042025-10-21WarningsExact identifier
application number: M020
DEWYTREE URBAN SHADE HYALURONIC LIGHTWEIGHT SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEDEWYTREE CO. ,LTD2f1ca6e0-f689-57c7-e063-6394a90a3da52025-10-21WarningsExact identifier
application number: M020
TOSOWOONG Rice Glow SunScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMANTONG Co., Ltd.3e9120fd-1c2f-1546-e063-6394a90a9e462025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - BuffHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.857666da-2b4a-4a4a-aa25-ed6fd9b6a1632025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - IvoryHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V62031860-2e28-4b25-82bd-29b874b24d842025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - CocoaHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.40e6473a-8363-4503-bde0-6c151296fb342025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Golden TanHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.7f4a185c-85c7-43bf-8695-c01a3aecec0d2025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - NaturalHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V383aabdf-3feb-4407-9d85-27c11cb3e78c2025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - ShellHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V4585b1c8-e477-44d7-a3ad-a9efc3d699b72025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Soft IvoryHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V1e9efb61-06ad-4d2d-a81d-46aba72f75142025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- BisqueHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.Vffc421e1-26eb-44e7-b03c-5fab761a51b22025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Natural TanHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V3617d26e-a94c-4665-988b-95dbbc5270172025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- HoneyHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.55be05c0-429a-4ae0-bb86-1120bb1905ff2025-10-21WarningsExact identifier
application number: M020
Sun face protector sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8e1ced7-dafa-c71e-e053-2995a90a95502025-10-21WarningsExact identifier
application number: M020
Jafra Sun sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b9316e16-c571-4a5c-e053-2995a90ac6a82025-10-21WarningsExact identifier
application number: M020
Jafra Sun tinted face protector sunscreen broad spectrum 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8df67f8-57d9-ddc1-e053-2995a90a50c62025-10-21WarningsExact identifier
application number: M020
Sonni SunDay Invisible DefenseTITANIUM DIOXIDE, ZINC OXIDESonni41ad9658-7906-d04c-e063-6394a90a47232025-10-21WarningsExact identifier
application number: M020
Sonni SunDay Body BalmTITANIUM DIOXIDE, ZINC OXIDESonni41adca2e-cf69-ccd9-e063-6294a90a0dc02025-10-21WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC0b625d48-9632-0464-e063-6394a90a9adc2025-10-21WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Deep 530 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.940e0b2d-0b10-4534-ba36-e9980cead4922025-10-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-753-424903507534229.6 mL in 1 JAR (49035-753-42) 29.6 ml2019-08-120000-00-00NoNoCurrent