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 79 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50ZINC OXIDENoble Panacea Labs, Inc.aed57f81-4b7d-42dc-993e-6bb10f93b02a2026-01-16WarningsExact identifier
application number: M020
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd0d9f132c-7630-4261-a0f8-fc7a4377731f2026-01-16WarningsExact identifier
application number: M020
BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdf292da7d-ffd2-41c3-9a64-619aab19ff182026-01-15WarningsExact identifier
application number: M020
Multivit Sun ProtectorTITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltdabdb560d-29be-41dc-ad23-54ea571acb142026-01-15WarningsExact identifier
application number: M020
BeautyBarrierZINC OXIDENAKED SUNDAYS PTY LTD45740afa-230d-4dd5-e063-6394a90a102f2026-01-15WarningsExact identifier
application number: M020
Glow This WayOCTISALATE, OCTOCRYLENE, ZINC OXIDE, AVOBENZONE, HOMOSALATEKoco Life LLC4619cf96-987a-3e88-e063-6294a90afbe92026-01-15WarningsExact identifier
application number: M020
Reef safe lip balm 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.486930f2-026b-14b4-e063-6394a90aa0312026-01-15WarningsExact identifier
application number: M020
DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENECLINIQUE LABORATORIES LLC316bf6f8-7d30-2560-e063-6294a90afb8a2026-01-15WarningsExact identifier
application number: M020
Wellcare Sunstick Lip BalmAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATEBAMKO, LLCef977575-7ef0-fc09-e053-2a95a90a89932026-01-15WarningsExact identifier
application number: M020
Bali Body Sheer Glow Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd4872793c-a7c0-1b65-e063-6394a90a8b3a2026-01-15WarningsExact identifier
application number: M020
Getaway Glow SPF 30 Radiant Sunscreen Broad Spectrum SPF 30 SunscreenZINC OXIDEVolition Beauty2631de4b-66e3-0547-e063-6394a90a822c2026-01-15WarningsExact identifier
application number: M020
AGE RESET Restore Plus Protect Day Cream Broad Spectrum SPF 30ZINC OXIDESKINN COSMETICS, LLC350ed168-ab3b-f314-e063-6394a90a8bbf2026-01-15WarningsExact identifier
application number: M020
StriVectin TL Advanced Tightening Neck and Chest Broad Spectrum SPF 35 SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEStriVectin Operating Company, Inc.4873a262-a19b-555e-e063-6394a90a182a2026-01-15WarningsExact identifier
application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENThe Center Brands, LLCe843bb6b-257f-4425-95bc-41774e032a092026-01-15WarningsExact identifier
application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENThe Center Brands, LLC1e18f1dd-a4e4-455a-9699-5634b95596782026-01-15WarningsExact identifier
application number: M020
First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company485c345f-0928-fa1a-e063-6294a90aa8562026-01-14WarningsExact identifier
application number: M020
NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC19af4441-31b2-72db-e063-6394a90a813c2026-01-14WarningsExact identifier
application number: M020
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30ZINC OXIDESqween LLC9c3cf35b-4bde-46e3-8abd-5f4d1ad6e4862026-01-14WarningsExact identifier
application number: M020
SCENTUAL AROMA BEAUTY SUN VEIL SPF30TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES DRUIDE INC0799ac38-9a41-6579-e063-6394a90ac4b62026-01-14WarningsExact identifier
application number: M020
NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC0b412e24-baf6-e68e-e063-6394a90a5f492026-01-14WarningsExact 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