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 22 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unseen Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESupergoop LLC21b3491f-7b02-9bc5-e063-6294a90a0dc32026-06-04WarningsExact identifier
application number: M020
Mineral Glowscreen Soft-Radiance Drops Golden HourZINC OXIDESupergoop LLC1f1be2a7-af96-d73d-e063-6394a90acc1a2026-06-04WarningsExact identifier
application number: M020
Play Antioxidant Body Mist WIth Vitamin C Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC975402e6-8c74-b18e-e053-2995a90a467e2026-06-04WarningsExact identifier
application number: M020
Derma E Sun Drops SPF 30ZINC OXIDEderma e76c29f24-e0d9-4235-b278-96e609bc58db2026-06-04WarningsExact identifier
application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
application number: M020
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
application number: M020
BLDG Active Skin Repair Sun Stick Performance SunscreenZINC OXIDEInnovacyn, Inc.a751fc1d-5ee4-4ecc-8ade-2568d91890c42026-06-02WarningsExact identifier
application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCAREHOMOSALATE OCTOCRYLENE ETHYLHEXYL SALICYLATEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5347c9a1-2239-b617-e063-6294a90ac6012026-06-02WarningsExact identifier
application number: M020
Sungboon Editor Hydro Booster Moisture SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEOlive International Co., Ltd.4ea2292a-571c-475c-a64c-cbdd1f51f2422026-06-02WarningsExact identifier
application number: M020
Sungboon Editor Daily Invisible Blurring SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOlive International Inc.42325963-0917-43c4-8fe0-130336c7fa812026-06-02WarningsExact identifier
application number: M020
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
application number: M020
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
application number: M020
4ocean REEF SAFE SUNSCREEN SPF 40ZINC OXIDEStream2Sea, LLC52d3d97c-a846-4721-acbe-52a525cb20112026-06-01WarningsExact identifier
application number: M020
APRILSKIN MUGWORT CALMING SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAPR US INC50a7b64a-8b26-97ac-e063-6294a90ad77a2026-06-01WarningsExact identifier
application number: M020
Ultra Violette Future Screen Broad Spectrum SPF 50ZINC OXIDEGrace and Fire USA Inc.252fdc91-bbe2-58ec-e063-6294a90a50672026-06-01WarningsExact identifier
application number: M020
Ultra Violette Vibrant Screen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.2633a289-b3b2-b614-e063-6294a90ad2142026-06-01WarningsExact identifier
application number: M020
Ultra Violette Sequin Supreme SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEGrace and Fire USA Inc.41027faa-7d61-4970-e063-6294a90a7df42026-06-01WarningsExact 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