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 312 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETekweld Solutions, Inc.ea9f4d57-b00c-48ce-b833-9690be98bffd2023-12-26WarningsExact identifier
application number: M020
Best Skin Days BS SPF 30ZINC OXIDEAllure Labs0d7072f8-e808-5270-e063-6294a90a1ffa2023-12-26WarningsExact identifier
application number: M020
Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incf0d6518b-d795-4740-a301-1804a932ec452023-12-23WarningsExact identifier
application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy GlowOCTINOXATEL'Oreal USA Products Inc4f4a8c37-af08-4bf7-89bc-1e487417c1462023-12-23WarningsExact identifier
application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy GlowOCTINOXATESICOS ET CIE7051f505-f874-4214-ad4f-55a956cc35a72023-12-23WarningsExact identifier
application number: M020
Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating DayAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc08645f1d-7ba7-4410-8600-3d3f79d713852023-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift and Firming Face and Neck All Skin TypesAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incfc847725-b7a9-41f1-a605-d1d892fed06f2023-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift Firming Face Neck For All Skin TypesAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEdf67b49c-f8b6-4c0a-9e8d-c94dee3635ff2023-12-23WarningsExact identifier
application number: M020
Lancome Paris Absolue Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 DayAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEa9b7e52c-8799-49ba-8b05-7559fe6668fe2023-12-23WarningsExact identifier
application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen fairTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.32569352-c51e-4f05-a8b0-749ef916a5af2023-12-22WarningsExact identifier
application number: M020
Circadia Circa-Shield Mineral Sunscreen SPF 30ZINC OXIDECircadia by Dr Pugliese, Inc.2959aa56-be7f-4721-9701-e6d6e12cc8502023-12-22WarningsExact identifier
application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc0adb52f5-4e1f-4570-9b6f-584e4da61d9f2023-12-22WarningsExact identifier
application number: M020
ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCc670635a-63d8-4b0b-afd7-b26e969f93a12023-12-21WarningsExact identifier
application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 16N fair-light neutralTITANIUM DIOXIDETarte, Inc.62fffef6-29ae-4137-b0b9-fb93d61679332023-12-21WarningsExact identifier
application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 12N fair neutralTITANIUM DIOXIDETarte, Inc.889860fc-7fce-47e9-af28-a3b2aec04a0e2023-12-21WarningsExact identifier
application number: M020
JLo Beauty That Big Screen Broad Spectrum SPF 30 MoisturizerHOMOSALATE, OCTISALATE, AND ZINC OXIDEAscendant Beauty LLCcba4e886-c4c6-4377-8f4c-250aef4b95fb2023-12-21WarningsExact identifier
application number: M020
COOLA Full Spectrum 360 Refreshing Water Cream SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLCd12e30bd-88ee-4e34-ae63-c34766aed3a82023-12-20WarningsExact identifier
application number: M020
COOLA Liplux Hydrating Oil SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC2d2ad94c-ea13-43c0-ab7f-acecf4d2309f2023-12-20WarningsExact identifier
application number: M020
Coola Bare Republic Mineral Face-Lotion SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%COOLA LLCa334a61d-5c5a-4f45-b202-6dd7bb3d250b2023-12-20WarningsExact identifier
application number: M020
Bare Republic Big Adventure Stick SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%COOLAe800f72f-8c8b-4a12-843f-1ee404055cf02023-12-20WarningsExact 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