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 228 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Classic Body SPF 50 Guava MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed13afaa-35ec-8326-e053-2995a90adaf02025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2102c6-02ea-3a8f-e063-6394a90abf5e2025-02-14WarningsExact identifier
application number: M020
Sunscreen Broad Spectrum SPF 50 Vi AestheticsZINC OXIDE, OCTINOXATEVi Medical Products, INC73620765-c7c0-4bd7-82a9-00022773c9282025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2297d4-3649-a749-e063-6294a90ac2842025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e22cfde-10a1-3742-e063-6394a90ac0972025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2e5c2add-8ed0-a990-e063-6394a90a87ea2025-02-14WarningsExact identifier
application number: M020
Les Duets - Shield of Helios, sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f75a5-6a3b-a129-e063-6394a90a52a02025-02-14WarningsExact identifier
application number: M020
Le Mieux Naked Glow Bronzer SPF 50SUNSCREENYB CHEMIA LLC46465db7-c1f0-6980-e063-6294a90a3ed82025-02-14WarningsExact identifier
application number: M020
Sheer Tint Mineral SPF Serum - Light LightZINC OXIDEMineral Fusion brandsac6fdc35-82f8-4805-875e-2aa91aedec6f2025-02-14WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 50ZINC OXIDEPeer Pharm Ltd.3989eebc-7262-4cda-84a1-ca30b638b7722025-02-13WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 30ZINC OXIDEPeer Pharm Ltd.8ee9f97b-9081-4e0c-aa7a-27a31cbee17a2025-02-13WarningsExact identifier
application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Medium DeepZINC OXIDEPeer Pharm Ltd.45ed56e1-46cb-46de-b11a-e814a7446e572025-02-13WarningsExact identifier
application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Light MediumZINC OXIDEPeer Pharm Ltd.6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a2025-02-13WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Dry Touch SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe99311c2-ed8b-6e60-e053-2a95a90a9bc22025-02-13WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC525f7bae-44b8-44e4-93ea-32995eca25662025-02-13WarningsExact identifier
application number: M020
DreamBeam Sunscreen SunlitSUNSCREEN ZINC OXIDEKosas Cosmetics, LLC2e093b82-2a36-cc0f-e063-6394a90a4d6d2025-02-13WarningsExact identifier
application number: M020
DreamBeam SunscreenSUNSCREEN ZINC OXIDEKosas Cosmetics, LLCf93b0091-6a41-ae6e-e053-6394a90a86d72025-02-13WarningsExact identifier
application number: M020
Revealer Skin-Improving FoundationSUNSCREEN ZINC OXIDEKosas Cosmetics, LLC2e0a0cd6-c302-2017-e063-6394a90a60b82025-02-13WarningsExact identifier
application number: M020
Hi papa KIDS MINERAL FACE SUNSCREENSUNSCREENGUANG DONG 3 INS TECHNOLOGY Co., Ltd2deea723-32a0-da33-e063-6294a90accdd2025-02-12WarningsExact 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