FDA.reportPublic FDA data

Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30

Product NDC
63354-421
11-digit product format
633540421
Labeler code
63354
Product ID
63354-421_25dc8df3-8b85-95b0-e063-6394a90ac575
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-01
Marketing end
2026-10-31
Substance
ZINC OXIDE
Active strength
15 g/100g
NDC exclude flag
No
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 Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
c8d6c731-2dfc-71c0-e053-2a95a90aa5b8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-421-12Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30100 g in 1 BOTTLE, PUMPLOTION1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-421HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]4Current NDC, Legacy NDC, 1 package rows20241103_c8d6c731-2dfc-71c0-e053-2a95a90aa5b8.zip

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 181 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
application number: M020
Skinny Dip SPF-50ZINC OXIDECove Suncare LLC7bef2966-9351-4ea6-aeed-0d568376d86b2025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0f0ba2e9-126f-13c0-e063-6394a90aa6a42025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC08997bd4-d6b9-fffc-e063-6294a90a77ae2025-10-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC75f81b2d-cabc-443f-b4b5-76bd2321826b2025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC1390f863-709e-412b-9a25-b65217844e442025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCccc2e40b-5301-4055-8a89-47366687cfb72025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0f0dd2e4-3dda-c872-e063-6294a90a20a32025-10-08WarningsExact identifier
application number: M020
ScalpHair MistSunscreen SPF30COOLA SCALPHAIR MIST ORGANIC SUNSCREEN SPF30COOLA LLCc7d2098f-6fdf-68e5-e053-2a95a90a18982025-10-08WarningsExact identifier
application number: M020
Block Party SPF-50ZINC OXIDECove Suncare LLC24ffb6ec-d922-40c0-b325-c15f8433027a2025-10-08WarningsExact identifier
application number: M020
Sun Kids mineral BLUEBERRY SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDEThe Natural SKN Company40945805-6f2e-74a1-e063-6394a90a04a32025-10-07WarningsExact identifier
application number: M020
ProtecTINT 10NHOMOSALATE, OCTISALATE, ZINC OXIDESupergoop, LLC0801287f-0df5-4303-e063-6394a90a503b2025-10-07WarningsExact identifier
application number: M020
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
application number: M020
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
application number: M020
SPF50 SunscreenSUNSCREENKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDb3cde609-7d62-2ac7-e053-2a95a90a26b32025-10-07Exact identifier
application number: M020
Summer Face Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESUMMER GELEE LLCfe256ff4-cb92-4262-8ab9-7cc912e0af222025-10-06WarningsExact identifier
application number: M020
Sun Veil Broad Spectrum SPF50ZINC OXIDEMONAT GLOBAL CORP3ba28de7-74a2-5cde-e063-6394a90add262025-10-06WarningsExact identifier
application number: M020
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEToshiki Pigment Co., Ltd.b9eba15f-493a-43c9-e053-2995a90a04512025-10-06WarningsExact identifier
application number: M020
Apple Lip Balm with Aloe VeraBROAD SPECTRUM SPF 15 SUNSCREEN LIP BALMDurvet, Inc.6dcbb2cd-e690-4970-8cf1-08ca539d36022025-10-06WarningsExact identifier
application number: M020
PURE SOL SPF 50 Daily MoisturizerZINC OXIDEBrand 2022b LLC4051506c-fc13-cd22-e063-6394a90a977e2025-10-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-421-1263354042112100 g in 1 BOTTLE, PUMP (63354-421-12) 100 g2021-10-012026-10-31NoNoCurrent