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 19 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FHF Elevated Shade 100% Mineral SunscreenSUNSCREENSummer Soles, LLC dba Farm House Freash Goods5488fd8c-7ef2-22c2-e063-6394a90aff3c2026-06-18WarningsExact identifier
application number: M020
Stream2Sea Sport Lip Balm SPF 50ZINC OXIDEStream2Sea, LLC5489fea5-bc0e-82cf-e063-6294a90aa0972026-06-18WarningsExact identifier
application number: M020
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
application number: M020
UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC4a6f9be3-2a56-8b41-e063-6294a90a30f82026-06-18WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50MINERAL SUNSCREENALAINA HEALTHCARE PRIVATE LIMITED7e036f9f-b26d-4f11-911c-c1fa854edb0f2026-06-17WarningsExact identifier
application number: M020
Not there spf broad spectrum spf40 moisturizerAVOBENZONE 3% ,HOMOSALATE 10% ,OCTISALATE 5% ,OCTOCRYLENE 8% ,ZINC OXIDE 4%Foshan Sugar Max Cosmetics CO.,Ltd546f0474-4102-26d0-e063-6394a90a388b2026-06-17WarningsExact identifier
application number: M020
Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40ZINC OXIDEGrace and Fire USA Inc.52d4b1c1-7431-4f8c-e063-6294a90ad4822026-06-17WarningsExact identifier
application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF30ZINC OXIDEMoes Group LLC54751f23-5723-0407-e063-6294a90a4a962026-06-17WarningsExact identifier
application number: M020
Amber Sunglaze Sheer Body Mist Sunscreen SPF30AVOBENZONE, OCTISALATE, OCTOCRYLENEKoco Life LLC5478fb36-e972-f824-e063-6294a90a567f2026-06-17WarningsExact identifier
application number: M020
Elaine Sterling Hydrating SunscreenZINC OXIDEElaine Sterling Enterprises5479e862-aca5-7541-e063-6394a90ad0c52026-06-17WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS545aa56a-ed07-acd6-e063-6394a90ae0c72026-06-16WarningsExact identifier
application number: M020
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREENOCTISALATELOreal USA Products Inc3b99ab06-ba4c-4ddd-a057-60028eedd67d2026-06-16WarningsExact identifier
application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREENZINCOXIDEMoes Group LLC54617bf2-1d8d-531e-e063-6294a90a70802026-06-16WarningsExact identifier
application number: M020
Daily Defence Mineral Sunscreen SPF 50 Fragrance FreeZINC OXIDEUltraceuticals Pty Ltd5461ee82-0297-ce22-e063-6294a90a729b2026-06-16WarningsExact identifier
application number: M020
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
application number: M020
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
application number: M020
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC546b0702-a3cc-fd6f-e063-6394a90af8492026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 30ZINC OXIDEWhole Foods Market, Inc.5ce712d6-cafd-4a80-9f8c-2149fdebff542026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 50ZINC OXIDEWhole Foods Market, Inc.1f8387be-d871-435b-baef-e537c67a510a2026-06-15WarningsExact 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