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 292 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bitchstix Very Raspberry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77e9c3-cffe-0bb6-e063-6294a90aacd12024-07-17WarningsExact identifier
application number: M020
Bitchstix The Original SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchistix, LLC1d78148a-586c-2f7d-e063-6294a90a46912024-07-17WarningsExact identifier
application number: M020
Derma E Sun Defense Face SPF 30ZINC OXIDE TITANIUM DIOXIDEderma ed90b8f81-de7a-4022-800a-90f063e941802024-07-17WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
application number: M020
CVS Beauty 360 7-in-1 Complete Daily Moisturizer Anti-Aging Formula with Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyfa412c9d-2a8b-bf71-e053-6394a90a8a632024-07-16WarningsExact identifier
application number: M020
CVS Health SPF 50 ClearAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf42402ff-0d70-9231-e053-2995a90aa46d2024-07-16WarningsExact identifier
application number: M020
CVS Health Sunburn Relief CoolingLIDOCAINE HYDROCHLORIDECVS PHARMACY1d6402ea-4201-27f9-e063-6294a90a43f52024-07-16WarningsExact identifier
application number: M020
NYX Professional Makeup Blurscreen Primer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6ca01ccb-07f8-4d2c-84bb-6b251e73dad22024-07-16WarningsExact identifier
application number: M020
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8df98d97-a5d2-4d52-8bd2-130a13501d602024-07-16WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC1d4cab02-8897-6449-e063-6294a90ad72e2024-07-15WarningsExact identifier
application number: M020
the beach people SPF 50ZINC OXIDEThe Beach People United LLC2e5176e2-e2f4-4b08-8528-cb1ee3c166592024-07-15WarningsExact identifier
application number: M020
Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production23235897-c1fc-423f-99a2-e2ad282ee7442024-07-14WarningsExact identifier
application number: M020
LOreal Paris Bright Reveal Broad Spectrum SPF 50 Daily UV SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc96d72471-de95-4668-8903-aed6187633a92024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60TITANIUM DIOXIDECosmetique Active Productiona3b5dfe5-c726-4f9c-8e4d-0e9808480d4b2024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60TITANIUM DIOXIDELOreal USA Products Inc2e85cf6e-a2a7-4871-bdb6-1d72088c30312024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc664c67cc-7d63-45d7-abdd-157c041b0d3f2024-07-14WarningsExact identifier
application number: M020
SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDEL'Oreal USA Products Inc817c882d-72f3-4ee7-8da2-a4a32f9d167f2024-07-14WarningsExact identifier
application number: M020
Sun Wrangler Daily Mineral Sunscreen SPF 45ZINC OXIDESun Wrangler1d0e94f1-2996-c058-e063-6294a90a343b2024-07-12WarningsExact identifier
application number: M020
Derma E Sun Defense SPF 30ZINC OXIDE AND TITANIUM DIOXIDEderma e395b73a4-dae7-49da-9dab-ab622117c8c02024-07-12WarningsExact identifier
application number: M020
the beach people SPF 30ZINC OXIDEThe Beach People United LLC3a7cc69a-6027-4dfd-b9ef-9d4390fe630c2024-07-12WarningsExact 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