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 320 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alba Botanica Sport SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Inc.fd78fb8e-99b0-91b0-e053-6394a90a92712023-11-16WarningsExact identifier
application number: M020
Alba Botanica Kids SPF 50 Tropical FruitAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Incf6941bab-1e97-1dc8-e053-2995a90a93172023-11-16WarningsExact identifier
application number: M020
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a4cea12-7e00-d201-e063-6394a90a66912023-11-16WarningsExact identifier
application number: M020
SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATECLINIQUE LABORATORIES LLCfb841fd7-0c78-01a1-e053-6394a90a43822023-11-15WarningsExact identifier
application number: M020
Banana Boat Kids Sport Sunscreen Roll-On UVA/UVB Broad Spectrum SPF 60 PlusAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7563a84-f622-dad6-e053-2a95a90aa8d92023-11-15WarningsExact identifier
application number: M020
Rite Aid Ryshi Facial Mist Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid0a3808e5-3f94-0544-e063-6294a90a823b2023-11-15WarningsExact identifier
application number: M020
HEB Solutions Sunscreen Face 50 Facial Mist SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6cdeb2f-fc58-1780-e053-6394a90a544a2023-11-15WarningsExact identifier
application number: M020
Rite Aid Ryshi Sunscreen with Hyaluronic Acid and Collagen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid0a3933b3-171f-8ce1-e063-6294a90a2d352023-11-15WarningsExact identifier
application number: M020
Rite Aid Ryshi Sunscreen Face Primer Shea Butter, Aloe, Mineral Oil, and Vitamin E Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid0a39957a-798d-b0a9-e063-6294a90a135d2023-11-15WarningsExact identifier
application number: M020
Rite Aid Mineral Sensitive Skin Zinc Oxide Sunscreen For Face SPF 50ZINC OXIDERite Aid0a39c146-a7a0-cde6-e063-6294a90a16a72023-11-15WarningsExact identifier
application number: M020
Beach Gypsy SPF-30OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEMJ Products Association, LLCa518e048-5614-4b67-b6fa-e1f2e380f3522023-11-15WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 MANGO-TANGOOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC1f4ea582-c4d5-4c0a-8fea-4eeb2fbb63272023-11-15WarningsExact identifier
application number: M020
Max MineralTITANIUM DIOXIDE, ZINC OXIDEPeter Thomas Roth Labs, LLC0980992c-6488-2fa1-e063-6294a90a41ea2023-11-14WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLCf1d46728-6933-4e6f-b7c0-3613466aa1f02023-11-14WarningsExact identifier
application number: M020
SIGNATURE CARE ACNE TREATMENTSALICYLIC ACIDSAFEWAY, INC.a60134d0-f788-90e8-e053-2a95a90acbde2023-11-14WarningsExact identifier
application number: M020
Curology the sunscreen broad spectrum SPF 30ZINC OXIDECurology Inc.e441895a-83b6-1cd5-e053-2995a90aab4b2023-11-14WarningsExact identifier
application number: M020
In Transit Skin DefenceAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONETHIS WORKS PRODUCTS LIMITEDc3425525-df4d-403b-ac7a-84067f0301182023-11-14WarningsExact identifier
application number: M020
Perfect Legs Skin Protector SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENETHIS WORKS PRODUCTS LIMITEDe0c54af2-9ea4-4dec-9d48-1048839508182023-11-14WarningsExact identifier
application number: M020
Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - SandZINC OXIDESLC Skincare935d0f47-048d-4823-bf08-8ece23e697362023-11-14WarningsExact identifier
application number: M020
Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - BronzeZINC OXIDESLC Skincaredefbb664-0a94-4ea6-b036-71782880151e2023-11-14WarningsExact 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