FDA.reportPublic FDA data

HYDRA SPF 34

Product NDC
83286-017
11-digit product format
832860017
Labeler code
83286
Product ID
83286-017_f3a36275-5980-40f3-ab1c-e69bf52d81a7
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octyl Salicylate, Avobenzone
Dosage form
STICK
Route
TOPICAL
Labeler
Drmtlgy, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength
10; 5; 3 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
HYDRA SPF 34
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE10 g/100g
OCTISALATE5 g/100g
AVOBENZONE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal 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
31e41ed5-8498-4e2d-928a-c15ca99775e4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83286-017-01HYDRA SPF 341 in 1 CARTONSTICK11
83286-017-01HYDRA SPF 3428 g in 1 TUBESTICK281

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
83286-017-01832860017011 TUBE in 1 CARTON (83286-017-01) / 28 g in 1 TUBE1 tube2026-01-01NoNoCurrent