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 132 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373cef98-a61d-dd36-e063-6394a90a7c3b2025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373d1e6c-9c32-20f5-e063-6294a90af86f2025-12-11Exact identifier
application number: M020
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373ddad0-ed33-a233-e063-6294a90a19cd2025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37263083-b24f-5a71-e063-6294a90aee7d2025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373d4fad-141c-0904-e063-6394a90a97592025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37265b3d-92ef-ef4a-e063-6294a90a8d952025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373d902f-f7b6-298b-e063-6394a90a93072025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726c177-2912-a6cc-e063-6394a90a00432025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726f463-7e55-c2a2-e063-6394a90a3c512025-12-11Exact identifier
application number: M020
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37617bd5-c275-aeee-e063-6394a90a214d2025-12-11Exact identifier
application number: M020
Not YO 80s Zinc SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.37644dfd-e96d-a783-e063-6294a90a97962025-12-11Exact identifier
application number: M020
Not YO 80s Zinc SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.3762f132-4ab0-74ad-e063-6394a90a436c2025-12-11Exact identifier
application number: M020
GLOW UP Ageless Daily Protection SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.37637e45-c6ed-12ca-e063-6294a90aeb022025-12-11Exact identifier
application number: M020
Face and Body SunscreenZINC OXIDESCIENCE CEUTICALS, LLC369b42f3-5203-87c4-e063-6394a90a62842025-12-11Exact identifier
application number: M020
Nourish Non-Tinted Mineral SunscreenZINC OXIDEFern Burg34a32097-de93-9b1d-e063-6394a90a41df2025-12-11Exact identifier
application number: M020
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37641f8b-0133-8bfc-e063-6294a90aac5c2025-12-11Exact identifier
application number: M020
GLOW UP Ageless Daily Protection SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.3764856a-98c5-334e-e063-6394a90a629d2025-12-11Exact identifier
application number: M020
Essential Mineral Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEFern Burg34a360b2-6798-c7e8-e063-6294a90a5cbb2025-12-11Exact identifier
application number: M020
Nourish Non-Tinted Mineral SunscreenZINC OXIDEFern Burg34a3e268-e376-11a0-e063-6294a90a46af2025-12-11Exact 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