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 125 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bee5f9-68d6-6302-e063-6394a90ada882025-12-15Exact identifier
application number: M020
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bfd54a-d7b7-f1a7-e063-6294a90a039b2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c03804-04e9-3d54-e063-6294a90a34072025-12-15Exact identifier
application number: M020
Deflectin Tinted Mineral SunscreenZINC OXIDEAEON AESTHETICS LLC35d14660-8900-2cb0-e063-6394a90a317d2025-12-15Exact identifier
application number: M020
Mineral Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf36c1-50c9-e848-e063-6294a90a66582025-12-15Exact identifier
application number: M020
Flash Invisible StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d2489e-4978-4fc3-e063-6294a90adfcc2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c010ad-e25d-f197-e063-6294a90a0efb2025-12-15Exact identifier
application number: M020
Flash Tinted StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d28590-e746-7996-e063-6294a90ac7d82025-12-15Exact identifier
application number: M020
Mineral Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf03f4-200a-5643-e063-6394a90a9e022025-12-15Exact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf708c-244e-63a8-e063-6394a90a3b962025-12-15Exact identifier
application number: M020
Daily RestoreZINC OXIDETYRLIN ENTERPRISES, INC.35cead50-86a7-2cf2-e063-6294a90a5f992025-12-15Exact identifier
application number: M020
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e81e8e-0ba7-93e6-e063-6294a90a4e622025-12-15Exact identifier
application number: M020
Sacred AuraZINC OXIDEIRIA SKIN OASIS LLC36eaaa54-e288-6590-e063-6394a90a403d2025-12-15Exact identifier
application number: M020
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e84147-5dcd-517a-e063-6394a90a54ee2025-12-15Exact identifier
application number: M020
Sacred GlowZINC OXIDEIRIA SKIN OASIS LLC36ead65c-a46c-7395-e063-6394a90a9e042025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen Non TintedZINC OXIDELAURA CATHERINE, LLC36e91877-c4c4-7fa3-e063-6294a90a13262025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen TintedZINC OXIDELAURA CATHERINE, LLC36e880af-debc-657f-e063-6394a90ab6ff2025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen TintedZINC OXIDELAURA CATHERINE, LLC36e8b631-03e7-c1de-e063-6294a90aa5302025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen Non TintedZINC OXIDELAURA CATHERINE, LLC36e957cf-cfa5-b122-e063-6294a90a78ce2025-12-15Exact identifier
application number: M020
Skin Shield PlusZINC OXIDELAURA CATHERINE, LLC36e9c2f3-ea89-0de3-e063-6394a90a9fb62025-12-15Exact 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