FDA.reportPublic FDA data

COOLA BARE REPUBLIC CLEARSCREEN SPF100

Product NDC
79753-021
11-digit product format
797530021
Labeler code
79753
Product ID
79753-021_46069245-ad40-caf7-e063-6394a90ab0c9
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
COOLA, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-21
Substance
HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
150; 30; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL
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 BARE REPUBLIC CLEARSCREEN SPF100
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE150 mg/mL
AVOBENZONE30 mg/mL
OCTOCRYLENE100 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f14cf2b8-b110-1210-e053-2995a90a0102Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-021-01COOLA BARE REPUBLIC CLEARSCREEN SPF10059 mL in 1 TUBELOTION593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-021COOLA BARE REPUBLIC CLEARSCREEN SPF100 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA, LLC]2Current NDC, Legacy NDC, 1 package rows20241025_f14cf2b8-b110-1210-e053-2995a90a0102.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 105 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord3bd710b-7d1a-4f96-9fbc-a67c550d863b2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior3b6ea0ec-4636-43cf-a324-a82666108e952025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5ac7fb96-a2f2-4086-82ad-c45d7a7090912025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior84a5f7e1-1c04-43cd-8d3b-60c7e2418faf2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior28a61b11-5901-47ec-916c-e2ae4f79a11d2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5ddf8221-9bfc-4c52-9a51-a0d725b7a23e2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5937248a-b96e-490a-9f93-10e65969ac102025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2cc7d9f6-f789-4f9b-91b7-73f9d0fee85c2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior62136c4c-6f05-4de0-a71e-55aa531606852025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora8037741-ec57-43e7-adb4-2a93941ee1082025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6f872199-067e-40aa-bf34-549ecc33b1ac2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4f27a485-1e8b-4f34-99a8-0d0a3cf1b9db2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior938a5c4a-b9dd-4089-8b20-7030f032591d2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4COCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1357ab72-0d73-41da-8f55-7bd6d97c9ae82025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d63bdc5-5338-48c4-9c59-bfb9900ab9202025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora315ed9c-bc19-40e9-85ab-50ac1daa54492025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora63ea887-cbe0-4a04-ad62-4d3a87ece1132025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior15c50e40-b97d-4612-a533-cf9d1d57b4172025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior63711abf-e906-4c07-bc2d-f8e10fead2f02025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior21455f0c-0190-4519-a8e3-34206d1f7a422025-12-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-021-017975300210159 mL in 1 TUBE (79753-021-01) 59 ml2021-10-210000-00-00NoNoCurrent