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 53 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3cc62d-9e2f-c929-e063-6294a90a913a2026-03-17WarningsExact identifier
application number: M020
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
application number: M020
SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50TITANIUM DIOXIDE, ZINC OXIDESummer Friday's LLC4d3e982f-3489-dce2-e063-6294a90a1b9d2026-03-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream410 NMelaleuca Inc.2f380433-3369-9d05-e063-6394a90a64792026-03-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream115 NMelaleuca Inc.2f132cc0-e8e3-35e3-e063-6394a90a4f3d2026-03-17WarningsExact identifier
application number: M020
Tinted Sunscreen Broad SPF30TINTED SUNSCREEN BROAD SPF30DOSCHER FAMILY HEALTH NP P.C.4d4021ba-4b29-6b81-e063-6294a90a5ea72026-03-17WarningsExact identifier
application number: M020
SOME BY MI TRUECICA AQUA CALMING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPERENNEBELL Co., Ltd.4d42d5aa-d12e-1086-e063-6294a90a12df2026-03-17WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECLIO COSMETICS Co., Ltd.bce6008b-3dab-44e4-9a07-d996bf652d072026-03-17WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 23ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d206947-1e89-7ef1-e063-6394a90a7d072026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 25ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d207687-b58f-916d-e063-6394a90a737f2026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 31ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d20a060-fedd-d2f2-e063-6294a90a5cc02026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 27ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d210edf-0966-87c8-e063-6394a90a30c72026-03-16WarningsExact identifier
application number: M020
Advanced Formula Lip Balm SPF 25 Blood OrangeAVOBENZONE, OCTINOXATEAnthony Skin LLC74853b40-a773-4488-98a9-c8029ad211342026-03-16WarningsExact identifier
application number: M020
Advanced Formula Lip Balm SPF 25AVOBENZONE, OCTINOXATEAnthony Skin LLC74d7bc30-db15-4cfc-8918-40897d54da702026-03-16WarningsExact identifier
application number: M020
CVS SPF 70 Sport Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS26e66240-97ae-103d-e063-6394a90a9b5a2026-03-16WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beierdorf Incf2a06097-b066-8631-e053-2a95a90a9ffc2026-03-16WarningsExact identifier
application number: M020
Ultra Light Invisible SPF 40 sunscreenHOMOSALATE 8%, OCTISALATE 5.0%, AVOBENZONE 3.0%, OCTOCRYLENE 4.0%RK Shea LLC02d59d96-0edb-472c-b730-148a2eb4fa4a2026-03-16WarningsExact identifier
application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 SOFT SANDZINC OXIDECOSMAX USA4d31038e-a032-3ce9-e063-6394a90a889d2026-03-16WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce3d79b-fec5-8501-e063-6294a90a479d2026-03-15WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce59571-132a-c633-e063-6294a90a8d972026-03-15WarningsExact 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