FDA.reportPublic FDA data

Drops

Product NDC
80641-013
11-digit product format
806410013
Labeler code
80641
Product ID
80641-013_2e99f7af-047a-769c-e063-6394a90a1406
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone Octisalate Octocrylene
Dosage form
LIQUID
Route
TOPICAL
Labeler
Vacation Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-07
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
2.9; 4.9; 7.6 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
Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.9 g/100mL
OCTISALATE4.9 g/100mL
OCTOCRYLENE7.6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal 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
1319d6ea-a580-79c5-e063-6394a90a4dcaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-013-01Drops1 in 1 KITLIQUID14
80641-013-80Drops30 mL in 1 BOTTLE, DROPPERLIQUID304
80641-013-94Drops30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-013DROPS (AVOBENZONE OCTISALATE OCTOCRYLENE) LIQUID [VACATION INC.]4Current NDC, 3 package rows20250223_1319d6ea-a580-79c5-e063-6394a90a4dca.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 53 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3cc62d-9e2f-c929-e063-6294a90a913a2026-03-17WarningsExact identifier
application number: M020
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
application number: M020
SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50TITANIUM DIOXIDE, ZINC OXIDESummer Friday's LLC4d3e982f-3489-dce2-e063-6294a90a1b9d2026-03-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream410 NMelaleuca Inc.2f380433-3369-9d05-e063-6394a90a64792026-03-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream115 NMelaleuca Inc.2f132cc0-e8e3-35e3-e063-6394a90a4f3d2026-03-17WarningsExact identifier
application number: M020
Tinted Sunscreen Broad SPF30TINTED SUNSCREEN BROAD SPF30DOSCHER FAMILY HEALTH NP P.C.4d4021ba-4b29-6b81-e063-6294a90a5ea72026-03-17WarningsExact identifier
application number: M020
SOME BY MI TRUECICA AQUA CALMING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPERENNEBELL Co., Ltd.4d42d5aa-d12e-1086-e063-6294a90a12df2026-03-17WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECLIO COSMETICS Co., Ltd.bce6008b-3dab-44e4-9a07-d996bf652d072026-03-17WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 23ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d206947-1e89-7ef1-e063-6394a90a7d072026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 25ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d207687-b58f-916d-e063-6394a90a737f2026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 31ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d20a060-fedd-d2f2-e063-6294a90a5cc02026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 27ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d210edf-0966-87c8-e063-6394a90a30c72026-03-16WarningsExact identifier
application number: M020
Advanced Formula Lip Balm SPF 25 Blood OrangeAVOBENZONE, OCTINOXATEAnthony Skin LLC74853b40-a773-4488-98a9-c8029ad211342026-03-16WarningsExact identifier
application number: M020
Advanced Formula Lip Balm SPF 25AVOBENZONE, OCTINOXATEAnthony Skin LLC74d7bc30-db15-4cfc-8918-40897d54da702026-03-16WarningsExact identifier
application number: M020
CVS SPF 70 Sport Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS26e66240-97ae-103d-e063-6394a90a9b5a2026-03-16WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beierdorf Incf2a06097-b066-8631-e053-2a95a90a9ffc2026-03-16WarningsExact identifier
application number: M020
Ultra Light Invisible SPF 40 sunscreenHOMOSALATE 8%, OCTISALATE 5.0%, AVOBENZONE 3.0%, OCTOCRYLENE 4.0%RK Shea LLC02d59d96-0edb-472c-b730-148a2eb4fa4a2026-03-16WarningsExact identifier
application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 SOFT SANDZINC OXIDECOSMAX USA4d31038e-a032-3ce9-e063-6394a90a889d2026-03-16WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce3d79b-fec5-8501-e063-6294a90a479d2026-03-15WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce59571-132a-c633-e063-6294a90a8d972026-03-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-013-01806410013011 BOTTLE, DROPPER in 1 KIT (80641-013-01) / 30 mL in 1 BOTTLE, DROPPER (80641-013-94) 2024-03-07NoNoCurrent
80641-013-808064100138030 mL in 1 BOTTLE, DROPPER (80641-013-80) 30 ml2024-03-07NoNoCurrent
80641-013-948064100139430 mL in 1 BOTTLE, DROPPER30 mlHistorical