FDA.reportPublic FDA data

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 130 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359641c5-0e19-f243-e063-6394a90aeebc2025-12-12Exact identifier
application number: M020
Satin TintZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359684cf-ca11-f9af-e063-6394a90ac4c12025-12-12Exact identifier
application number: M020
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
application number: M020
JAYSUING Rice Probiotics SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.45cdc741-9ce0-fd6c-e063-6294a90adc0b2025-12-12WarningsExact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
application number: M020
Signature Tint SPF 40ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348f1bd3-1245-2d9a-e063-6394a90a47872025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348fcc63-d8e3-90a1-e063-6294a90ade112025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a54441-c741-0c46-e063-6294a90a9be82025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37620171-140d-e096-e063-6294a90af93b2025-12-11Exact identifier
application number: M020
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a52011-b781-75cf-e063-6394a90ae0f42025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a632f5-4458-e335-e063-6394a90a9bcb2025-12-11Exact identifier
application number: M020
D FEND DAILYZINC OXIDECLEAN BEAUTY BY ANAK LLC3762dc16-055e-43fd-e063-6394a90ad3c82025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a66140-0d36-005a-e063-6394a90a2a0b2025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37634726-fb70-f209-e063-6294a90a5d3b2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3761d74c-0137-0c75-e063-6394a90a3c7d2025-12-11Exact identifier
application number: M020
Sun Plus Sun Lip ShieldTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3763a79a-e881-cade-e063-6394a90a49de2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact 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