FDA.reportPublic FDA data

Equate

Product NDC
49035-765
11-digit product format
490350765
Labeler code
49035
Product ID
49035-765_249ea048-6834-7ac8-e063-6394a90a6d91
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form
SPRAY
Route
TOPICAL
Labeler
Wal-Mart Stores Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-12
Substance
HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
150; 60; 30; 50; 40 mg/g; mg/g; mg/g; mg/g; mg/g
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
HOMOSALATE150 mg/g
OXYBENZONE60 mg/g
AVOBENZONE30 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
95OOS7VE0YInternal 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
9b655e56-33e5-45a3-9174-356fc717e39dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-765-37EquateSPF 70 Ultra Sunscreen156 g in 1 CANISTERSPRAY1564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-765EQUATE SPF 70 ULTRA SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [WAL-MART STORES INC]4Current NDC, Legacy NDC, 1 package rows20241018_9b655e56-33e5-45a3-9174-356fc717e39d.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 279 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS HEALTH SPORT SPF 50 CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf13f7361-56b3-7ea8-e053-2995a90a76412024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 50 Ultra ProtectionAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf11650bb-90a0-78a1-e053-2995a90a8e4c2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacyf31dd448-dc79-21f1-e053-2a95a90a7bb62024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Breakout Free FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41478c8-76c0-727f-e053-2a95a90a86692024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra ProtectionAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf12ba764-afea-3f81-e053-2a95a90a12912024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf32ec4ef-352e-6a78-e053-2995a90af4912024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf40e5664-e3ca-badf-e053-2a95a90a913e2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf799bad7-b3df-f9a5-e053-6294a90ab1042024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41e145c-896e-2782-e053-2995a90a5f812024-10-17WarningsExact identifier
application number: M020
CVS Health AM Moisturizing Facial Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDECVS PHARMACYf9c89108-1568-ee3e-e053-6294a90ac7562024-10-17WarningsExact identifier
application number: M020
CVS Health 50 Clear Zinc Broad Spectrum SPF 50 SunscreenOCTOCRYLENE, ZINC OXIDECVS PHARMACYfa19e9d3-6ab8-cbd6-e053-6294a90aae9b2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 30 ClearAVOBENZONE, HOMOSALATE, OCTOCRYLENECVS PHARMACYfbe6ae15-28ef-2acf-e053-6394a90a8d422024-10-17WarningsExact identifier
application number: M020
CVS Health 45 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyfc4addf0-9a6e-292f-e053-6294a90ab9c02024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 70AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYfc4a79ce-208e-2aed-e053-6394a90a06bb2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENECVS PHARMACYfc4bbb80-c3f6-c4f7-e053-6394a90a4cae2024-10-17WarningsExact identifier
application number: M020
SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INCee782436-9eff-49e4-8edc-fd9783454c072024-10-17WarningsExact identifier
application number: M020
GLOW RECIPE WATERMELON GLOW DEW BALM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATEAramara Beauty LLC dba Glow Recipe0c437f88-c731-5834-e063-6394a90a32992024-10-17WarningsExact identifier
application number: M020
SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INC5ce3e436-37d1-4918-bb14-0be33b0bc86a2024-10-17WarningsExact identifier
application number: M020
MARKET BASKET KIDS SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INC.a6a381da-6e34-bffe-e053-2a95a90a46f22024-10-17WarningsExact identifier
application number: M020
Market Basket Continuous Sunscreen SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEDEMOULAS SUPER MARKETS, INC.f4238107-c76c-266a-e053-2a95a90a89782024-10-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-765-3749035076537156 g in 1 CANISTER (49035-765-37) 156 g2019-08-120000-00-00NoNoCurrent