FDA.reportPublic FDA data

COOLA Refreshing Water Mist SPF 18

Product NDC
54111-148
11-digit product format
541110148
Labeler code
54111
Product ID
54111-148_aae99fc7-d6b1-44fc-a2d8-0004df757b85
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Bentley Laboratories, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-30
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2; 10; 5; 5.5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
COOLA Refreshing Water Mist SPF 18
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2 g/100mL
HOMOSALATE10 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE5.5 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
658bf3fe-2246-40b6-8cb1-969bfdaffd1bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-148-50COOLA Refreshing Water Mist SPF 181 in 1 CARTONSPRAY13
54111-148-50COOLA Refreshing Water Mist SPF 1850 mL in 1 BOTTLESPRAY503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-148COOLA REFRESHING WATER MIST SPF 18 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [BENTLEY LABORATORIES, LLC]3Current NDC, Legacy NDC, 2 package rows20231220_658bf3fe-2246-40b6-8cb1-969bfdaffd1b.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 146 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safe Sea SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD46641a33-d658-4ef0-9b7a-062adc401dde2025-12-08WarningsExact identifier
application number: M020
Skin Filter Glow SPFZINC OXIDEMALORIE MILES36485f44-a6bd-9529-e063-6294a90af7a42025-12-08Exact identifier
application number: M020
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3647f983-9e75-8955-e063-6294a90af1622025-12-08Exact identifier
application number: M020
Body-ScreenZINC OXIDEMALORIE MILES36499be5-d680-92bf-e063-6394a90a89db2025-12-08Exact identifier
application number: M020
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3649f758-e31b-3c6a-e063-6294a90a5c362025-12-08Exact identifier
application number: M020
Body-ScreenZINC OXIDEMALORIE MILES364ae392-480a-14ea-e063-6394a90a38832025-12-08Exact identifier
application number: M020
Personalized Moisturizer SPF 30ZINC OXIDE 10.00%Proven Skincared3cf8f81-d6ae-4570-ad86-43415e973e132025-12-08WarningsExact identifier
application number: M020
GLOW SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2f9d087c-b2b3-5654-e063-6294a90a94e52025-12-08WarningsExact identifier
application number: M020
MATTE SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2faee7ef-fc0c-6d01-e063-6294a90a6d682025-12-08WarningsExact identifier
application number: M020
GLOW SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2faf530d-5574-b702-e063-6294a90ad6fd2025-12-08WarningsExact identifier
application number: M020
MATTE SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2fb00db0-4c37-56c6-e063-6294a90a8aff2025-12-08WarningsExact identifier
application number: M020
Matte Shield SPFTITANIUM DIOXIDE, ZINC OXIDEACNE SOLUTIONS NYC INC3bb582ec-71e7-4ad8-e063-6394a90a94d42025-12-08WarningsExact identifier
application number: M020
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334afdc8-1e12-d787-e063-6294a90aed7c2025-12-08Exact identifier
application number: M020
SPF 101 Non-TintedZINC OXIDEThe Acne Lab LLC334bf8ea-2485-84e8-e063-6294a90aefa62025-12-08Exact identifier
application number: M020
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334d694a-f9e4-ae86-e063-6394a90abfe12025-12-08Exact identifier
application number: M020
SPF 101 Non-TintedZINC OXIDEThe Acne Lab LLC334e32a4-c3a5-e37d-e063-6294a90ad6cf2025-12-08Exact identifier
application number: M020
Mineral Based Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245561d-a90c-7bf0-e063-6394a90ab3b62025-12-08Exact identifier
application number: M020
Mineral Based Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245c1f7-2c1b-b6ad-e063-6394a90aaee62025-12-08Exact identifier
application number: M020
Mineral Based Facial SunscreenZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3e8981ed-5847-7009-e063-6394a90a49a12025-12-08WarningsExact identifier
application number: M020
Replenishing Daily Protection Sunscreen InvisibleZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32462e88-0e74-a675-e063-6294a90ac5642025-12-08Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54111-148-50541110148501 BOTTLE in 1 CARTON (54111-148-50) / 50 mL in 1 BOTTLE1 bottle2020-07-302023-12-31NoNoCurrent