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 289 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior105651f2-3c99-4ff3-b67b-350a40dc88882024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7b1b551b-e78d-47ff-bb91-0d5f676c73fc2024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2411e8e6-a958-4fd9-b5e9-b9a32020ce542024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior062f61d2-a9a7-46e1-92e4-a6bdf257c1882024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9c3d513f-8331-4155-a77b-c358093a607c2024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2CROCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb7f8d1d0-1734-46a5-82fe-b0ac140175222024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3COCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc3849d5c-4f91-4147-aeb2-7461a3a943092024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4COCTISALATE, TITANIUM DIOXIDEParfums Christian Diore8f29488-10f8-4df6-b1f5-d9a670f60fca2024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior86e0d1e4-3207-49e6-b5fa-e63f4ca300db2024-08-06WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd67b009-accc-6c7b-e053-6294a90ad80e2024-08-06WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Continuous SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.fd67fa5d-f997-c607-e053-6294a90aee2b2024-08-06WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd66ee9b-5a24-776a-e053-6294a90a65592024-08-06WarningsExact identifier
application number: M020
SANTO REMEDIOS RADIANCE SILKY MINERAL PRIMER SUNSCREEN SPF 42 IVORYTITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC0708ec87-16c4-412b-971b-d4572931c7802024-08-05WarningsExact identifier
application number: M020
EltaMD UV Physical SPF41ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc8fdc04eb-4079-40e3-a1b3-be4a542cf99a2024-08-05WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATEJungsaemmool Beauty Co., Ltd.6377c0f7-e2cb-44f0-9786-42c5a9d02f882024-08-04WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion LightTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATEJungsaemmool Beauty Co., Ltd.e98696d2-7f7f-4a4c-b8ae-849f2d211a042024-08-04WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATEJungsaemmool Beauty Co., Ltd.f31842f7-3474-4462-87e2-c4ebde97a5832024-08-04WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATEJungsaemmool Beauty Co., Ltd.ccfafefc-fff4-41ff-baf4-3f430c690be72024-08-04WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF50ZINC OXIDEThe Hain Celestial Group, Inc.f4a02196-288e-1958-e053-2a95a90a53052024-07-31WarningsExact identifier
application number: M020
Very Emollient Body Daily Shade SPF15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Hain Celestial Group8eeb25a8-337d-c71b-e053-2995a90a091a2024-07-31WarningsExact 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