FDA.reportPublic FDA data

COOLA Classic Body Sunscreen Fragrance-Free

Product NDC
54111-145
11-digit product format
541110145
Labeler code
54111
Product ID
54111-145_5368324e-9b83-48dc-8ab3-88146d9423f8
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Bentley Laboratories, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-06
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
1.75; 5; 2; 5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54111-145-51fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54111-145-5186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54111-145-51bd6a592717d7…303034d00443…

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
COOLA Classic Body Sunscreen Fragrance-Free
Brand name suffix
SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.75 g/100mL
HOMOSALATE5 g/100mL
OCTISALATE2 g/100mL
OCTOCRYLENE5 g/100mL

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
57f2fdeb-2abc-4ad3-bb89-5faee883c0e5Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54111-145-512023-01-06C16284748780-1d6a99b39-6d3f-a426-e053-dadaa90af4c2COOLA CLASSIC BODY SUNSCREEN Fragrance-Free SPF 50
54111-145-512022-01-28C16284748780-1d6a99b39-6d3f-a426-e053-dadaa90af4c2COOLA CLASSIC BODY SUNSCREEN Fragrance-Free SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-145-51COOLA Classic Body Sunscreen Fragrance-FreeSPF 50148 mL in 1 TUBELOTION1486
54111-145-51COOLA Classic Body Sunscreen Fragrance-FreeSPF 501 in 1 BOXLOTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-145COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [BENTLEY LABORATORIES, LLC]6Current NDC, Legacy NDC, 2 package rows20231221_57f2fdeb-2abc-4ad3-bb89-5faee883c0e5.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 138 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
application number: M020
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
application number: M020
COVEREDZINC OXIDEPotency No. 710 LLC3118c3ed-f0f0-f997-e063-6294a90a53a92025-12-10WarningsExact identifier
application number: M020
COVEREDZINC OXIDEPotency No. 710 LLC3117faeb-1792-1b2e-e063-6294a90a92df2025-12-10WarningsExact identifier
application number: M020
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
application number: M020
Morning ReplenishZINC OXIDERestore Skin Therapy, LLC364b26c2-a1bb-9660-e063-6294a90a14d12025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen TintedZINC OXIDEFleur de Lune, LLC34288989-35b8-3aa3-e063-6394a90ac2c42025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen TintedZINC OXIDEFleur de Lune, LLC3418394b-fede-65ce-e063-6394a90ad5f92025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen Non-TintedZINC OXIDEFleur de Lune, LLC341871e5-c170-7560-e063-6394a90a8eee2025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen Non-TintedZINC OXIDEFleur de Lune, LLC3428bdbb-1f18-a29b-e063-6294a90addbc2025-12-10Exact identifier
application number: M020
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b2403-4f4a-3e77-e063-6294a90a4f0a2025-12-10Exact identifier
application number: M020
Sheer Mineral Sunscreen BarTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b69d5-f0e1-99cd-e063-6294a90abb6e2025-12-10Exact identifier
application number: M020
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342c3f42-c17f-f777-e063-6394a90a80582025-12-10Exact identifier
application number: M020
Lip SPFTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396d3fdd-99d8-77e8-e063-6294a90aec2f2025-12-10Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396cae82-7641-e1b2-e063-6394a90a7c072025-12-10Exact identifier
application number: M020
Solar Knight SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEMASCARENAS ENTERPRISES, INC.36c27c91-22ac-205c-e063-6294a90ab3792025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396ce15a-06ad-4055-e063-6294a90a27fb2025-12-10Exact identifier
application number: M020
Dermablue Daily ReplenishingZINC OXIDEDermablue, P.C.308da9c9-544e-d5d1-e063-6294a90aa49b2025-12-10WarningsExact identifier
application number: M020
Recoverie Mineral MatteZINC OXIDEClear Day Acne Clinic308f41de-fb14-40f9-e063-6394a90a008f2025-12-10WarningsExact identifier
application number: M020
AL0043600 Alba Botanica VE Herbal Healing BodyCOLLOIDAL OATMEALThe Hain Celestial Group, Inc.60672feb-141f-651e-e053-2a91aa0af41d2025-12-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54111-145-51541110145511 TUBE in 1 BOX (54111-145-51) / 148 mL in 1 TUBE1 tube2019-11-062023-12-31NoNoCurrent