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 161 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soft Bisque Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Ince8b11940-6ac4-4c80-a732-2f86f2b7ebfe2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Alabaster Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incd54a35a2-4f5d-4aec-8be4-1d8e00d4618f2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Alabaster Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incd6be5b8e-0094-40de-91a6-bc52b3f8a9872025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Creamy Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incda149594-8a75-4b8d-9b6a-068231ce153b2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Pure Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc95821b1c-c894-4b3f-94c2-0083497302032025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Porcelain Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inccce60274-ef8a-4638-a2c8-e869fc9e2a7c2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Quiet Rose Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc776f5cb5-9d0e-4057-9600-e18b2b8a249a2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Sandy Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc2406806e-f5ff-4c54-bf33-a96afaea1ccc2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Sesame Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc70b94df9-2160-450c-a722-cb842f58c3192025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Simply Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc7797fcb4-2080-415a-9b4b-5410518380932025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Soft Bisque Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Ince5a63ffc-32e6-4bb1-907a-8697791f57bf2025-11-19WarningsExact identifier
application number: M020
Vanilla Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc98ebaa5c-ba28-4e70-a45c-6545eb756d8f2025-11-19WarningsExact identifier
application number: M020
Softlips VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8dff782f-7201-4ad9-94d2-672058f817b82025-11-19WarningsExact identifier
application number: M020
Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum SPF30AVOBENZONE, OXTINOXATE, OCTOCRYLENE, OXYBENZONEBaxter Laboratories Pty. Ltd.43923c68-87ad-1ab7-e063-6394a90adf7a2025-11-18WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e36351-4caf-3393-e063-6394a90a00b12025-11-18WarningsExact identifier
application number: M020
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e454cf-dac8-4c2f-e063-6394a90a70972025-11-18WarningsExact identifier
application number: M020
Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEH.E.B.43e55eb7-6572-bd88-e063-6294a90aa7ee2025-11-18WarningsExact identifier
application number: M020
Bare Expert Finish Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incff396aca-cf64-45f8-ba2e-c4fc55d6484b2025-11-18WarningsExact identifier
application number: M020
ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMerle Norman Cosmetics, Inc.d10272ea-aedd-5759-e053-2a95a90a3ab32025-11-18WarningsExact identifier
application number: M020
DAYDREAM Broad Spectrum Sunscreen SPF 40ZINC OXIDEDrmtlgy, LLCbd0981cb-49ce-4eaf-bd9e-db48f56b73142025-11-18WarningsExact 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