FDA.reportPublic FDA data

Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30

Product NDC
63354-643
11-digit product format
633540643
Labeler code
63354
Product ID
63354-643_42ee75c3-c4a4-8a64-e063-6394a90a5796
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
OIL
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-01
Marketing end
2027-10-01
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
6; 4.3 g/100g; 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 Face Skin Nourishing Tinted Milk Coconut Oil SPF30

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE6 g/100g
TITANIUM DIOXIDE4.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eeb3c173-b280-76e4-e053-2995a90a0e79Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-643-11Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF3050 g in 1 BOTTLEOIL503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-643HAWAIIAN TROPIC MINERAL FACE SKIN NOURISHING TINTED MILK COCONUT OIL SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]2Current NDC, Legacy NDC, 1 package rows20231024_eeb3c173-b280-76e4-e053-2995a90a0e79.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 135 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Repair Moisturizing TintedZINC OXIDESkintique37de5a51-0bc4-34ad-e063-6294a90a0eef2025-12-11Exact identifier
application number: M020
Mineral SunscreenZINC OXIDELEILANI VIDAL36d51157-1bcd-79c8-e063-6394a90aba712025-12-11Exact identifier
application number: M020
Mineral SunscreenZINC OXIDELEILANI VIDAL36d4b998-c29c-ff89-e063-6394a90a12d82025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEILANI VIDAL36d5831a-7128-729a-e063-6394a90a80362025-12-11Exact identifier
application number: M020
Mineral Matte Non-Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac219bd-dfc8-fe22-e063-6394a90a4a8c2025-12-11WarningsExact identifier
application number: M020
Tinted Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac25d06-d885-48a2-e063-6294a90a0d0b2025-12-11WarningsExact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac27b6c-1341-1f05-e063-6394a90a98602025-12-11WarningsExact identifier
application number: M020
Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37287e4c-6fdf-62c5-e063-6394a90a12962025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37284de3-32d4-3611-e063-6394a90a63932025-12-11Exact identifier
application number: M020
Mineral Lip Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST3728ec6a-7de5-bbc5-e063-6294a90a31b72025-12-11Exact identifier
application number: M020
SUNerchi Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESYNERCHI MED SPA, INC.37db5721-2b32-d4d8-e063-6294a90a47d72025-12-11Exact identifier
application number: M020
SUNerchi Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESYNERCHI MED SPA, INC.37db14e1-f995-b649-e063-6294a90afd692025-12-11Exact identifier
application number: M020
208ZINC OXIDEPETER L. KOPELSON, M.D.351ce033-6bd0-574e-e063-6394a90af4482025-12-11Exact identifier
application number: M020
208ZINC OXIDEPETER L. KOPELSON, M.D.,351c9727-d7ac-9c3f-e063-6294a90a77212025-12-11Exact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDEMY FAVORITE PLACE SPA LLC351c0c1e-5712-1e23-e063-6394a90abe6f2025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESaving Face Skinspa Inc.351d27e3-00d4-8d31-e063-6394a90aaf722025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESaving Face Skinspa Inc.351db99e-262f-b67e-e063-6394a90a34182025-12-11Exact identifier
application number: M020
Replenishing Daily Protection NTZINC OXIDEMY FAVORITE PLACE SPA LLC351c5f6f-86e6-7219-e063-6294a90a37452025-12-11Exact identifier
application number: M020
Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDAISY'S SKIN TRANSFORMATION LLC37d9fbf5-d602-d3dc-e063-6394a90abe532025-12-11Exact identifier
application number: M020
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d53a7-be0b-4d7a-e063-6394a90a37c42025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-643-116335406431150 g in 1 BOTTLE (63354-643-11) 50 g2022-10-012027-10-01NoNoCurrent