FDA.reportPublic FDA data

HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey

Product NDC
67015-2035
11-digit product format
670152035
Labeler code
67015
Product ID
67015-2035_5d193517-de3c-e99d-e063-6394a90a9010
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Pierre Fabre USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-03
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
4.9; 13.7 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE4.9 g/100g
TITANIUM DIOXIDE13.7 g/100g

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-04-04HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
2023-04-04HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
2023-01-30HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
2023-01-30HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
2021-12-06HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
2021-12-06HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
2021-07-23HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
2021-07-23HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67015-2035-0HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey10 g in 1 CONTAINERCREAM104
67015-2035-1HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67015-2035HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 HONEY (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PIERRE FABRE USA INC.]4Current NDC, Legacy NDC, 2 package rows20240131_8ab57a9b-db89-1bf2-e053-2995a90a303a.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 130 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Satin TintZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359684cf-ca11-f9af-e063-6394a90ac4c12025-12-12Exact identifier
application number: M020
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
application number: M020
JAYSUING Rice Probiotics SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.45cdc741-9ce0-fd6c-e063-6294a90adc0b2025-12-12WarningsExact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
application number: M020
Signature Tint SPF 40ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348f1bd3-1245-2d9a-e063-6394a90a47872025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348fcc63-d8e3-90a1-e063-6294a90ade112025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a54441-c741-0c46-e063-6294a90a9be82025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37620171-140d-e096-e063-6294a90af93b2025-12-11Exact identifier
application number: M020
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a52011-b781-75cf-e063-6394a90ae0f42025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a632f5-4458-e335-e063-6394a90a9bcb2025-12-11Exact identifier
application number: M020
D FEND DAILYZINC OXIDECLEAN BEAUTY BY ANAK LLC3762dc16-055e-43fd-e063-6394a90ad3c82025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a66140-0d36-005a-e063-6394a90a2a0b2025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37634726-fb70-f209-e063-6294a90a5d3b2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3761d74c-0137-0c75-e063-6394a90a3c7d2025-12-11Exact identifier
application number: M020
Sun Plus Sun Lip ShieldTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3763a79a-e881-cade-e063-6394a90a49de2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact identifier
application number: M020
Non Tinted Mineral SunscreenZINC OXIDESPECKTRA6 LLC374e1c8e-5c5c-9198-e063-6294a90a3b882025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67015-2035-06701520350010 g in 1 CONTAINER10 gHistorical
67015-2035-1670152035011 CONTAINER in 1 CARTON (67015-2035-1) / 10 g in 1 CONTAINER (67015-2035-0) 1 container2019-06-030000-00-00NoNoCurrent