CVS Health SPF 50 Ultra Protection

Product NDC
51316-024
11-digit product format
513160024
Labeler code
51316
Product ID
51316-024_24af02e9-1a04-57e3-e063-6394a90ad845
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone Homosalate Octisalate Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
CVS PHARMACY
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-03
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 150; 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
CVS Health SPF 50 Ultra Protection
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE150 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
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal 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
f11650bb-90a0-78a1-e053-2995a90a8e4cAvailable 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
51316-024-11CVS Health SPF 50 Ultra Protection237 mL in 1 BOTTLELOTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-024CVS HEALTH SPF 50 ULTRA PROTECTION (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [CVS PHARMACY]2Current NDC, Legacy NDC, 1 package rows20241019_f11650bb-90a0-78a1-e053-2995a90a8e4c.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 276 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance FreeOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEBu Brands, LLC20b32aae-7f8b-44ed-a3df-706054fd68832024-10-17WarningsExact identifier
application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEBu Brands, LLCd77be4d0-c08a-4d81-b5df-a9bae38e3b972024-10-17WarningsExact identifier
application number: M020
FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREENHOMOSALATE, OCTISALATEFRUIT OF THE EARTH, INC.13325a2a-f7f8-4019-acbb-205fd5dd13a52024-10-17WarningsExact identifier
application number: M020
FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.ae7951e9-54f6-4eab-81b6-a2b2c978851d2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Cabana Beach Clubwith Blood Orange and Essential Oils SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7805f3c-5b95-73bd-e053-2a95a90a99842024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Cabana Beach Club with Manuka Honey and Essential Oils SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7820ba9-7520-5139-e053-2a95a90ab92d2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Cabana Beach Club with Blood Orange and Essential Oils SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEFruit of the Earth, Inc.c7916317-c6a2-2eda-e053-2995a90a16282024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Cabana Beach Club with Mentha and Essential Oils SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c790031d-5448-a998-e053-2a95a90a763e2024-10-17WarningsExact identifier
application number: M020
Fruit of The Earth Sun Town City Kids SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c79472ea-a367-1328-e053-2a95a90a22d52024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Dark Tanning Dry Oil SPF 8 SunscreenHOMOSALATE, OCTISALATEFruit of the Earth, Inc.c7a94f68-a4d5-ec82-e053-2995a90a38fb2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7ba72c2-ea23-0bb9-e053-2a95a90a1d902024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEFruit of the Earth, Inc.c795cd2f-89dc-78e3-e053-2a95a90a94222024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7a4783f-477f-1524-e053-2995a90a5ad92024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 15 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7aaa185-8490-60ec-e053-2995a90adc0d2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Dark Tanning SPF 8 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7aa1e58-f7b3-6b7f-e053-2995a90a957c2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7bbad46-5c52-9f1d-e053-2995a90ae1392024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7bdd7a3-2e88-d881-e053-2a95a90a2ef92024-10-17WarningsExact identifier
application number: M020
dermalogica dynamic skin recovery spf 50SUNSCREENDermalogica, LLC051b77ab-6970-48e4-bbfd-c066178ea32e2024-10-17WarningsExact identifier
application number: M020
Hyaluronic MoisturizerOCTINOXATE, OXYBENZONE. AVOBENZONEBentley Laboratories LLC88bd6dff-ba19-4f8f-9432-28398d24f1ab2024-10-16WarningsExact identifier
application number: M020
EQUALINE SPORT CONTINUOUS SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf13feba4-25d8-61d0-e053-2995a90aafa82024-10-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-024-1151316002411237 mL in 1 BOTTLE (51316-024-11) 237 ml2019-01-030000-00-00NoNoCurrent