FDA.reportPublic FDA data

Hawaiian Blend Sensitive Zinc SPF 50

Product NDC
87313-005
11-digit product format
873130005
Labeler code
87313
Product ID
87313-005_47cfa4d4-cd8e-8d6d-e063-6394a90a6a4c
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
AEROSOL
Route
TOPICAL
Labeler
The Islander Group
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-03
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
4; 19.5 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
Hawaiian Blend Sensitive Zinc SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE4 g/100g
ZINC OXIDE19.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b42261c5-fa6e-4bb3-93c0-97032ab9f716Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87313-005-05Hawaiian Blend Sensitive Zinc SPF 50170 g in 1 CANAEROSOL1702

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 122 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extreme Protection Non TintedZINC OXIDEBIOHEALTH PLUS LLC3764cbeb-55f5-4a9c-e063-6394a90a863d2025-12-15Exact identifier
application number: M020
Happy Mineral Sunscreen Primer SPFTITANIUM DIOXIDE, ZINC OXIDEACNE CLINIC LAS VEGAS BY JUSTINA37d9c5f2-f414-6efa-e063-6294a90a927f2025-12-15Exact identifier
application number: M020
Comfort Mineral Mousse SunscreenTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC3765dd17-ffbd-bcf4-e063-6394a90a2c2b2025-12-15Exact identifier
application number: M020
Prime And Protect DewyZINC OXIDEKalon Skin Studio, LLC3593cefe-a08f-eb88-e063-6394a90aaff62025-12-15Exact identifier
application number: M020
GlowZINC OXIDEGODDESSLYNNEBODYANDSKIN37247365-33ee-563d-e063-6394a90a249e2025-12-15Exact identifier
application number: M020
Prime And Protect MatteTITANIUM DIOXIDE, ZINC OXIDEKalon Skin Studio, LLC35939630-1166-1c70-e063-6294a90aac6b2025-12-15Exact identifier
application number: M020
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36d9d83b-7da5-a006-e063-6394a90a9d842025-12-15Exact identifier
application number: M020
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36da1a55-c076-cdd9-e063-6294a90ac97c2025-12-15Exact identifier
application number: M020
Tinted Lip BalmTITANIUM DIOXIDE, ZINC OXIDEGoldberg, Howard S MD Inc3598205d-2e87-9292-e063-6294a90a1f2a2025-12-15Exact identifier
application number: M020
Tinted Daily Replenishing ProtectionZINC OXIDEGoldberg, Howard S MD Inc3597dccf-07a1-5cd9-e063-6294a90aca712025-12-15Exact identifier
application number: M020
Hydrating Mineral Zinc Oxide SPF 40ZINC OXIDESpalina LLC.35aa74c5-1bb3-9814-e063-6294a90a69992025-12-15Exact identifier
application number: M020
Mineral Tinted SPF40 with ceramidesZINC OXIDESpalina LLC.35ac3bd1-a4c1-5078-e063-6394a90afdc82025-12-15Exact identifier
application number: M020
Suns Out Funs OutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC46040acf-512e-c867-e063-6294a90ac2202025-12-15WarningsExact identifier
application number: M020
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3981c878-826d-f685-e063-6294a90acb242025-12-15Exact identifier
application number: M020
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984c4b7-94ee-2a8e-e063-6294a90ac24f2025-12-15Exact identifier
application number: M020
Ultra Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc833d-f231-5f52-e063-6394a90a37a62025-12-15Exact identifier
application number: M020
Ultra Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc4586-5e62-c9e7-e063-6294a90a276b2025-12-15Exact identifier
application number: M020
20Percent Zinc Total ProtectionZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bcaee1-001b-82da-e063-6394a90a4a0f2025-12-15Exact identifier
application number: M020
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.39821730-f6d1-c01a-e063-6394a90a026b2025-12-15Exact identifier
application number: M020
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984920a-feb9-169c-e063-6394a90a95682025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87313-005-0587313000505170 g in 1 CAN (87313-005-05) 170 g2023-01-03NoNoCurrent