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 47 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
application number: M020
Pro-Tect Sports Sunscreen SPF 20MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEABBE Laboratories, Inc.35869e8d-8e48-4b22-8af3-6964fe8ac1822026-04-09WarningsExact identifier
application number: M020
Sunright 50AVOBENZONE, HOMOSALATE, AND OCTINOXATENSE Products, Inc.b1b76481-da23-427f-9b34-b987019fa5322026-04-09WarningsExact identifier
application number: M020
ThinkBaby SPF 30ZINC OXIDEthinkOperations,LLC06862b00-c937-41af-ab5d-cea34160d0352026-04-09WarningsExact identifier
application number: M020
Nutricentials Day Dream ProtectiveHOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Inc.4a376e93-85e8-40a5-8641-d3e3d11fdeea2026-04-08WarningsExact identifier
application number: M020
celimax PORE SKIN CLARIFYING DAILY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEABSORBLAB Co., Ltd4edac8d8-523f-8b8b-e063-6294a90a1a252026-04-08WarningsExact identifier
application number: M020
AGE20S UV MINERAL PRIMING SUNSCREENZINC OXIDEAekyung Industrial Co., Ltd.43c1f70b-0664-40be-e063-6394a90a2b482026-04-08WarningsExact identifier
application number: M020
AGE20S SUNSCREEN DUOZINC OXIDE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAekyung Industrial Co., Ltd.4eef11cd-85a1-0e44-e063-6394a90a5d442026-04-08WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4a822-a7ab-b374-e063-6394a90a85082026-04-08WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4d44e-3421-535f-e063-6294a90a2fea2026-04-08WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef5baf7-00b1-97aa-e063-6294a90aab9c2026-04-08WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef5dcd4-b2d0-bcd1-e063-6294a90a871f2026-04-08WarningsExact identifier
application number: M020
Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef669b9-df00-8965-e063-6394a90ab3352026-04-08WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef6a60a-6634-e79b-e063-6394a90a3daa2026-04-08WarningsExact identifier
application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef6b5fb-5495-001c-e063-6394a90ab7b32026-04-08WarningsExact identifier
application number: M020
Sunright Lip BalmOCTINOXATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Inc.dfdb2d0a-c646-4c44-b648-e2fdd604cdc92026-04-08WarningsExact identifier
application number: M020
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
application number: M020
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
application number: M020
Vivaiodays SPF 30 Sunscreen with TurmericSPF 30 SUNSCREEN WITH TURMERIC5SENCO INC4ee0c93a-7f50-2bda-e063-6294a90abff42026-04-07WarningsExact 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