FDA.reportPublic FDA data

Equate

Product NDC
49035-760
11-digit product format
490350760
Labeler code
49035
Product ID
49035-760_249e84dd-99e9-0a47-e063-6394a90a58fc
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Wal-Mart Stores Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-04
Substance
OXYBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength
60; 150; 50; 100; 30 mg/mL; 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 70 Ultra Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBENZONE60 mg/mL
HOMOSALATE150 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
95OOS7VE0YInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f24e301-3fce-f9e3-e053-2a95a90affe4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-760-12EquateSPF 70 Ultra Sunscreen236 mL in 1 TUBELOTION2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-760EQUATE SPF 70 ULTRA SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WAL-MART STORES INC]3Current NDC, Legacy NDC, 1 package rows20241018_8f24e301-3fce-f9e3-e053-2a95a90affe4.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 193 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olay Total Effects Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEThe Procter & Gamble Manufacturing Company8de52cb2-b4d2-1e0d-e053-2995a90a5aca2025-08-19WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Sunscreen Lip BalmZINC OXIDESun Bum, LLC3cbfba65-5702-50b5-e063-6394a90a409d2025-08-19WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50ZINC OXIDESun Bum, LLC324e8ddb-89d2-08ca-e063-6294a90ab6c12025-08-19WarningsExact identifier
application number: M020
Sun Bum 70 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b02811d-dc66-fc6f-e063-6294a90aefc82025-08-18WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b058b74-27d0-8f8a-e063-6294a90aa02c2025-08-18WarningsExact identifier
application number: M020
PLAY Mineral Stick SPF 50 with Olive Fruit ExtractZINC OXIDESupergoop LLC3ca7e1ed-7cc7-76b0-e063-6394a90ade932025-08-18WarningsExact identifier
application number: M020
Sun Bum Mineral 30 Sunscreen 6 OZZINC OXIDESun Bum, LLC3b91a7e3-ce52-6aa0-e063-6394a90a15e72025-08-18WarningsExact identifier
application number: M020
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca8742f-67cb-a25c-e063-6394a90a46382025-08-18WarningsExact identifier
application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b154009-9c6f-eadf-e063-6394a90ae4242025-08-18WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear Sunscreen 6 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b162348-0222-490e-e063-6394a90ad4942025-08-18WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b169860-66bc-dd02-e063-6294a90a79742025-08-18WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Sunscreen Face 1.7 OZTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3b1729c5-d8ca-94c7-e063-6394a90a67a52025-08-18WarningsExact identifier
application number: M020
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca914e2-cd53-42bf-e063-6294a90a70822025-08-18WarningsExact identifier
application number: M020
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3b1a0596-b852-16be-e063-6394a90a34982025-08-18WarningsExact identifier
application number: M020
Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZOCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3b29dbfc-0b92-eb0f-e063-6294a90a16e12025-08-18WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Sunscreen 32 OZZINC OXIDESun Bum, LLC3b2cb7cf-7e2c-0fd2-e063-6294a90a3b172025-08-18WarningsExact identifier
application number: M020
Sun Bum Sunscreen Oil 50 5 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b2b4ba0-3f89-0a04-e063-6294a90ac1c02025-08-18WarningsExact identifier
application number: M020
Sun Bum Signature Sunscreen Premium Zinc Lip Balm Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3ca9e9d3-1c73-7bd6-e063-6394a90ad2042025-08-18WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3caaea85-0dfe-6f69-e063-6294a90a7d4a2025-08-18WarningsExact identifier
application number: M020
PLAY Lip Shield SPF 30 - MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3cab1a7d-6226-9eba-e063-6294a90a8c4d2025-08-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-760-1249035076012236 mL in 1 TUBE (49035-760-12) 236 ml2019-06-040000-00-00NoNoCurrent