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 234 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
application number: M020
Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGalderma Laboratories, L.P.5b4e25ad-cd72-4960-9259-fc710bfd59da2025-01-27WarningsExact identifier
application number: M020
Well People Daygleamer Liquid Mineral Sunscreen SPF 34ZINC OXIDEe.l.f. Cosmetics, Inc.2c7621e9-0f1d-4712-e063-6294a90abd642025-01-24WarningsExact identifier
application number: M020
Equate Sunscreen SPF 30 SPORT Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENEWal-Mart Stores Inc1697628a-91d2-45bc-bd1b-91fb38f3f8df2025-01-24WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY SUN FLUIDHOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEHave & Be Co., Ltd.f06d8f90-f3df-6d76-e053-2a95a90af1f82025-01-24WarningsExact identifier
application number: M020
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
application number: M020
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
application number: M020
natural lip balm SPF15(unflavored) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.2c5a460a-dc93-14cc-e063-6294a90a0b612025-01-23WarningsExact identifier
application number: M020
360 by QUR Lemon Verbena lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb14c2-9181-5970-e053-2a95a90a41612025-01-23WarningsExact identifier
application number: M020
Soleo Organics SunscreenZINC OXIDESE Operations Pty Ltd59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b2025-01-22WarningsExact identifier
application number: M020
Neptune Ave. High Dive Barrier Repair Moisturizer Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENENeptune Ave. Inc.25034563-6420-daf6-e063-6394a90af9802025-01-22WarningsExact identifier
application number: M020
Jafra Sun body protector sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8e49dd6-305c-f717-e053-2995a90a659c2025-01-22WarningsExact identifier
application number: M020
Jafra Royal Defy Sample KitAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.c3b265b1-ab84-4ea9-b283-c92f5a4cf4612025-01-22WarningsExact identifier
application number: M020
SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODYAVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.2c4eaf2e-b034-8185-e063-6394a90a82752025-01-22WarningsExact identifier
application number: M020
Herbalife SKIN Protective Moisturizer Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDEHerbalife International of America Inc.d30b7cf1-73bb-3568-e053-2995a90ad5792025-01-21WarningsExact identifier
application number: M020
Herbalife Herbal Aloe Face and Body Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEHerbalife International of America, Inc.d30d9d02-bc31-db3c-e053-2a95a90a0dab2025-01-21WarningsExact identifier
application number: M020
Sugargirl Disco Stick SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC36f30834-62be-4076-9493-f385720a1e222025-01-20WarningsExact identifier
application number: M020
Sugargirl Glowy Face Screen Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONEI World LLC757897b0-fc65-4147-8444-2a0efdc6f81c2025-01-20WarningsExact identifier
application number: M020
Sugargirl Hot Body Screen Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OCTISALATEI World LLCa9bf1342-1c4b-48ad-a955-715647df125a2025-01-20WarningsExact 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