FDA.reportPublic FDA data

Drops

Product NDC
80641-013
Requested package NDC
80641-013-01
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 104 of 354 · 7,077 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 2.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora89af40e-cf45-4afc-aac7-5f71a05bcd3f2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6da72e20-f2d7-492e-9b65-b5ac73bc00292025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1CROCTISALATE, TITANIUM DIOXIDEParfums Christian Diorde615c3e-669f-493c-9c75-73dfbe726c592025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior152790ba-aeda-4c2a-b725-7e040e8328832025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc87e5201-f7fd-4fd9-adeb-d6af9be00db62025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior84cdaad2-5b7d-4841-bef6-ffad4fe6907a2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00OCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb4caa2bc-8118-4137-8834-25800f8e5e012025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc0fa32fe-faa7-4a47-906c-14db01e55d472025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 8NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorff1a8b32-c01f-4910-9a7a-c74eb49c05a02025-12-19WarningsExact identifier
application number: M020
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing 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