FDA.reportPublic FDA data

Expedition BackCountry SPF 30

Product NDC
52854-976
11-digit product format
528540976
Labeler code
52854
Product ID
52854-976_42ca829d-656b-d2e4-e063-6294a90a7985
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octisalate, avobenzone
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-10
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
5; 3; 2.5 g/100g; g/100g; g/100g
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
Expedition BackCountry SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE5 g/100g
OCTISALATE3 g/100g
AVOBENZONE2.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
06d43525-86d8-f2d9-e063-6394a90afc81Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-976-01Expedition BackCountry SPF 304.44 g in 1 TUBELIPSTICK4.443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-976EXPEDITION BACKCOUNTRY SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) LIPSTICK [TROPICAL SEAS, INC.]2Current NDC, 1 package rows20241103_06d43525-86d8-f2d9-e063-6394a90afc81.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 267 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf5a006d1-e957-4063-9b45-2874a1445a332024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6943a531-c4e7-4e98-9970-3a30b9681b7b2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora74102d3-b535-4419-8e21-e961980e489d2024-11-11WarningsExact identifier
application number: M020
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50TITANIUM DIOXIDE AND ZINC OXIDEDARPHIN DIST.91277514-4db0-4b40-b95a-3530cac711df2024-11-11WarningsExact identifier
application number: M020
DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAveda Corporationdfa84bcc-a9b4-426d-8733-35f58c40e94d2024-11-11WarningsExact identifier
application number: M020
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYfef47045-1d3c-4f08-acec-e96abefbc2612024-11-08WarningsExact identifier
application number: M020
MeleNO SHADE SUNSCREEN OILCONOPCO Inc. d/b/a Unileverbd969eab-1da6-76a8-e053-2995a90a5c472024-11-07WarningsExact identifier
application number: M020
Vaseline Men plus Care Hydrate FaceAGING CHEST AND NECK RESCUE TREATMENT CREAMCONOPCO Inc. d/b/a Unileverbd0a9f3c-eaa9-47d0-e053-2995a90ab6172024-11-07WarningsExact identifier
application number: M020
VaselineAGING CHEST AND NECK RESCUE TREATMENT CREAMCONOPCO Inc. d/b/a Unileverbd965bbc-c9d1-c8da-e053-2995a90a22582024-11-07WarningsExact identifier
application number: M020
St. Ives Men plus Care Hydrate FaceSOLUTIONS CLEAR SKIN MOISTURIZER SUNSCREENCONOPCO Inc. d/b/a Unileverbcbaaa15-479d-b130-e053-2a95a90afa3b2024-11-07WarningsExact identifier
application number: M020
Dove Men plus Care Hydrate FaceAVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENECONOPCO Inc. d/b/a Unilever5c28d679-3f92-49e3-8bef-de1c3870f0092024-11-07WarningsExact identifier
application number: M020
Mele Men plus Care Hydrate FaceNO SHADE SUNSCREEN OILCONOPCO Inc. d/b/a Unileverbb2921bc-8892-1db2-e053-2995a90ae28c2024-11-07WarningsExact identifier
application number: M020
PondsREJUVENESS ANTI-WRINKLE DAILY MOISTURIZER WITH SUNSCREEN SPF 30CONOPCO Inc. d/b/a Unilever736ee790-99f7-686c-e053-2a91aa0ad16e2024-11-07WarningsExact identifier
application number: M020
Mele Men plus Care Hydrate FaceDEW THE MOST SHEER MOISTURIZER SUNSCREENCONOPCO Inc. d/b/a Unileverbb27185b-5732-a648-e053-2a95a90aa9302024-11-07WarningsExact identifier
application number: M020
PondsCLARANT B3 EVEN SKIN TONE DAILY MOISTURIZER WITH SUNSCREEN SPF 30CONOPCO Inc. d/b/a Unilever736ee790-9a15-686c-e053-2a91aa0ad16e2024-11-07WarningsExact identifier
application number: M020
Byoma Ultralight Face Fluid SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBYOMA LIMITED2657bca4-bdc7-d959-e063-6394a90a2aa12024-11-07WarningsExact identifier
application number: M020
Byoma Ultralight Face Fluid SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBYOMA LIMITED2658df86-8cbb-83dd-e063-6394a90ac4e82024-11-07WarningsExact identifier
application number: M020
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY547388c6-378b-488b-89d1-c77ebc5d2ed82024-11-07WarningsExact identifier
application number: M020
SPF30 SUMMER BLEND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY9641b71a-81f2-4157-801b-162188392a912024-11-07WarningsExact identifier
application number: M020
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd79cf2d9-4923-452a-bb44-67e059ee37ee2024-11-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52854-976-01528540976014.44 g in 1 TUBE (52854-976-01) 4.44 g2023-08-10NoNoCurrent