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 241 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDELG H&H Co., Ltd.0166d193-fc4d-51f7-e063-6294a90aaf322025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6e831a1-c82f-3e1f-e053-2a95a90ae1f62025-01-01WarningsExact identifier
application number: M020
ISA KNOX LXNEW PLATINUM SCULPTING DAY BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6e82b4e-ce84-0ca2-e053-2a95a90a88de2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.016798a8-4275-47d0-e063-6294a90a5aca2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDELG H&H Co., Ltd.f1166cb4-b471-7043-e053-2a95a90a7fa72025-01-01WarningsExact identifier
application number: M020
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.f8361aa8-c3ad-0c47-e053-6394a90a6ab02025-01-01WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6807577-56a1-a40c-e053-2995a90a59352025-01-01WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.0289088d-3316-c90c-e063-6294a90a69e02025-01-01WarningsExact identifier
application number: M020
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.a4364c8d-8b74-130e-e053-2995a90ad1c12025-01-01WarningsExact identifier
application number: M020
b.tan Tropic Like Its Hot SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarque of Brands Americas, LLCbb15b1bc-cfc0-0bab-e053-2a95a90af5b32025-01-01WarningsExact identifier
application number: M020
Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMDTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLCff95a7b7-3cb4-41b0-866d-69361354a0bc2025-01-01WarningsExact identifier
application number: M020
Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 SUNSCREENAVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONEObagi Cosmeceuticals LLC84f0f1dd-13f2-49f5-89b3-fab175ac25642025-01-01WarningsExact identifier
application number: M020
NU-DERM HEALTHY SKIN PROTECTION SPF 35OCTINOXATE AND ZINC OXIDEObagi Cosmeceuticals LLCcfb6a918-1403-4cf2-86d8-d66dd764bb6c2025-01-01WarningsExact identifier
application number: M020
CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENELaboratoires Clarinsc6dffe5c-5539-4e86-bf5e-b0e497eb9c882024-12-31WarningsExact identifier
application number: M020
Badger Adventure Sport Clear Mineral Sunscreen SPF 50ZINC OXIDEW.S. Badger Company, Inc.d10290b4-3c8a-e0bb-e053-2995a90a9b6b2024-12-31WarningsExact identifier
application number: M020
Badger BROAD SPECTRUM SPF 15 Lip BalmZINC OXIDEW.S. Badger Company, Inc.d506ac39-5019-1291-e053-2995a90a796a2024-12-31WarningsExact identifier
application number: M020
Badger Kids Mineral Sunscreen Cream Broad Spectrum SPF 40ZINC OXIDEW.S. Badger Company, Inc.d619d2b4-bae8-bc76-e053-2995a90a369b2024-12-31WarningsExact identifier
application number: M020
Badger SPF 35 Kids Clear Face StickZINC OXIDEW.S. Badger Company, Inc.d1038442-ec86-07e3-e053-2995a90ad6ab2024-12-31WarningsExact identifier
application number: M020
Badger Baby Sunscreen Cream Broad Spectrum SPF 40ZINC OXIDEW.S. Badger Company, Inc.d61acaa0-73ef-eccf-e053-2995a90ad9402024-12-31WarningsExact identifier
application number: M020
Badger Broad Spectrum SPF 35 Active Face StickZINC OXIDEW.S. Badger Company, Inc.d61b0dc8-3864-d5e3-e053-2a95a90ac02f2024-12-31WarningsExact 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