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 243 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.c3bacceb-63a8-098c-e053-2995a90acd642025-01-02WarningsExact identifier
application number: M020
Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16ZINC OXIDEREJUVA MINERALS INC3d83c220-1801-4193-b6a8-c777f412c1732025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SaddleZINC OXIDEEVER FAME PTE. LTD.2abf69c5-07d7-252d-e063-6394a90a292b2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SandZINC OXIDEEVER FAME PTE. LTD.2abf7869-4418-7738-e063-6394a90ae89d2025-01-02WarningsExact identifier
application number: M020
Good Weather Skin The One Daily Sun SPF 30ZINC OXIDEGood Weather Inc.2ac30544-5ece-18ed-e063-6394a90a6a0d2025-01-02WarningsExact identifier
application number: M020
Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plusOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.283c2780-5ad5-38f1-e063-6294a90ac3362025-01-01WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aabf782-65f9-e894-e063-6394a90a1ea32025-01-01WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aad5b97-e64b-c678-e063-6294a90aa8c62025-01-01WarningsExact identifier
application number: M020
TIBENA ALWAYS REAL SUN BLOCK UV SPF 45AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENEKONAD CO LTD2aafbd33-710a-201e-e063-6294a90ab1bb2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30ac897-3a30-7bba-e053-2995a90ac3422025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot BeigeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30b0588-b0f4-39a8-e053-2a95a90abb352025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30aeaa6-3423-401c-e053-2a95a90a8fe92025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural BeigeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30afd94-8bcd-01bc-e053-2a95a90afb492025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd30b156a-b9b1-499b-e053-2a95a90ada6a2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd30b183d-a54d-752c-e053-2a95a90a24fc2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltdd6dcdb08-3407-90e1-e053-2a95a90a83bf2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltdd6de8135-3c70-2036-e053-2995a90a040b2025-01-01WarningsExact identifier
application number: M020
ISA KNOX LXNEW PLATINUM SCULPTING DAY BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltdd6deadbd-524f-7506-e053-2a95a90a0a1b2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDEfmg Co.Ltd02e61a43-3021-edc1-e063-6294a90ad4b62025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd02e64868-d545-4af7-e063-6394a90aa7c72025-01-01WarningsExact 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