FDA.reportPublic FDA data

Equate

Product NDC
49035-759
11-digit product format
490350759
Labeler code
49035
Product ID
49035-759_249e9a6e-b52d-0c56-e063-6394a90a6664
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Wal-Mart Stores Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-04
Substance
HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
150; 30; 50; 70 mg/mL; mg/mL; 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 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE150 mg/mL
AVOBENZONE30 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal 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
8f02f297-5315-ced4-e053-2a95a90a8c7bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-759-12EquateSPF 50 Ultra Sunscreen236 mL in 1 TUBELOTION2365
49035-759-14EquateSPF 50 Ultra Sunscreen473 mL in 1 BOTTLE, PLASTICLOTION4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-759EQUATE SPF 50 ULTRA SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WAL-MART STORES INC]5Current NDC, Legacy NDC, 2 package rows20241018_8f02f297-5315-ced4-e053-2a95a90a8c7b.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 216 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LBEL FOREVER MATTE LONGWEAR AND CONTROL FOUNDATION 72H SPF 15 CHAMPAGNE 170NOCTINOXATE, ZINC OXIDEBEL STAR S.A.338c2c66-497a-f7d1-e063-6294a90a77892025-04-24WarningsExact identifier
application number: M020
The Ordinary UV Filters SPF 45 SerumHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATEDeciem10cde253-26ee-b97d-e063-6394a90a83022025-04-23WarningsExact identifier
application number: M020
BareBack sunscreen SPF50 infused with Hyaluronic acid and vitamin CZINC OXIDEVeganicSKN3123aab6-0407-19e5-e063-6394a90a5bd82025-04-23WarningsExact identifier
application number: M020
Sephora Daily Sunscreen Cream Broad Spectrum SPF 30ZINC OXIDES+b49e043b-8164-421c-a02b-3dab0be1454d2025-04-22WarningsExact identifier
application number: M020
YAYA Organics SPF-50 Sports CreamZINC OXIDEYAYA ORGANICS L.L.C.9eabf1f8-698b-4fa8-98d3-3696c35b044c2025-04-22WarningsExact identifier
application number: M020
YAYA Organics SPF-50 Baby Kids Mineral SunscreenZINC OXIDEYAYA ORGANICS L.L.C.3275303d-a448-4fb4-bdce-6442823f89962025-04-22WarningsExact identifier
application number: M020
Oathology Inzincable Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, ZINC OXIDESKINOATH LLCd245dfca-9e32-4e71-9df8-58fff84ef6a92025-04-22WarningsExact identifier
application number: M020
Back9ine Skincare Pure Invisible Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBack 9ine Skincare, LLC974ede40-cfb5-4612-b168-5d42dd137f632025-04-22WarningsExact identifier
application number: M020
AlgenistOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDESolazyme, Inc.4ece1847-1c94-4bf7-b936-109556a460a72025-04-22WarningsExact identifier
application number: M020
Sulwhasoo Perfecting Cushion NO.17N1 VanillaOCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATEAmorepacific Corporation3350f28e-22b4-904c-e063-6394a90a1c812025-04-21WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 PlusZINC OXIDEKenvue Brands LLCc914c4cd-99a2-4d9f-8f04-8af2ace3c3452025-04-18WarningsExact identifier
application number: M020
Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25ZINC OXIDECHARLIS LLC330f7470-0d53-7361-e063-6394a90a5d592025-04-18WarningsExact identifier
application number: M020
Chardonnay Lip OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc1318a429-d382-f5b8-e063-6394a90a3bd42025-04-18WarningsExact identifier
application number: M020
Shimmer OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc.131c63ba-57fc-9ce8-e063-6294a90acd922025-04-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC055431a6-e9e0-99b4-e063-6394a90acb112025-04-17WarningsExact identifier
application number: M020
SILKEN pore perfecting sunscreen broad spectrum SPF 35OCTISALATE, ZINC OXIDETATCHA INC.251566a1-0e21-4030-9d4e-52c4a8bd33302025-04-16WarningsExact identifier
application number: M020
Dermatone SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDermatone Labs LLC32e5bddf-a0b5-c511-e063-6294a90aaf662025-04-16WarningsExact identifier
application number: M020
Sunscreen Lip Balm SPF 30 Cool MintAVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%USRX3271ab14-3bf5-a24f-e063-6294a90a59bc2025-04-16WarningsExact identifier
application number: M020
goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECLIO COSMETICS Co., Ltd.77a0d190-f558-474b-89d2-c79b37c50c0d2025-04-16WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only - REFILLZINC OXIDESPF Ventures, LLC32ccb93a-50cf-f436-e063-6294a90a24922025-04-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-759-1249035075912236 mL in 1 TUBE (49035-759-12) 236 ml2019-06-040000-00-00NoNoCurrent
49035-759-1449035075914473 mL in 1 BOTTLE, PLASTIC (49035-759-14) 473 ml2019-06-040000-00-00NoNoCurrent