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 70 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields7fe05ef6-dd5f-4f25-bbf7-24f9396427072026-01-23WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen NacreCEILE SPF 30 PRIME PROTECT RADIATE NACRELE COSMETICS INC4915de09-3a2c-cb75-e063-6394a90a6a572026-01-23WarningsExact identifier
application number: M020
SPF 50 Sunscreen StickZINC OXIDEAustralian Gold248d761c-2120-4019-9463-9952bc367e732026-01-23WarningsExact identifier
application number: M020
SOLBAR THIRTYSUNSCREENPerson and Covey48ed3be8-d146-ec2c-e063-6394a90a6c4d2026-01-22WarningsExact identifier
application number: M020
MISSHA ALL AROUND ESSENCE SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAble C&C Co., Ltd.48f557b5-a844-8c94-e063-6394a90af2202026-01-22WarningsExact identifier
application number: M020
MISSHA GLOW DEWY HDRATING SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAble C&C Co., Ltd.48f5e9ab-38e0-f12c-e063-6294a90aab8b2026-01-22WarningsExact identifier
application number: M020
MISSHA GLOW WEIGHTLESS PRIMING SUNSCREENZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDEAble C&C Co., Ltd.48f6361d-d738-62df-e063-6294a90aaac52026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 35 AVOSUNSCREENPerson and Covey4a5692d5-0835-d18f-e063-6394a90a29292026-01-22WarningsExact identifier
application number: M020
Sunscreen Lip Balm SPF15OCTINOXATE, AVOBENZONE, OCTISALATEDongguan Taimeng Accessories Co., Ltd.48f70710-7960-5fa5-e063-6394a90a4ce62026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 40 ZINCSUNSCREENPerson and Covey48fc01dd-0be4-5c63-e063-6294a90a23622026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 40 SHIELDSUNSCREENPerson and Covey48fcd463-8ce4-1e78-e063-6394a90a98e72026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 50 FIFTYSUNSCREENPerson and Covey48fef521-1b24-d0d5-e063-6394a90ac7b12026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 110HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.7456f4bb-d0ec-439d-b807-d00b4c01c1112026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 121HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.2dd51960-515f-4502-b261-5e5d5f57e0912026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 140HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5b835716-af13-4e23-bdae-d391864acb6f2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 132HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.fa258570-ee21-423d-bad6-010d14792a862026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 212HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.fa84c1b5-a9b6-408e-b9fd-0dadebaf374e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 221HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.6b7a016c-c3b1-4f90-80c9-fe47c52916492026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 151HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5d029d93-7f3d-4624-bcd7-40df9230414e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 232HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.8f724d68-3c6e-4b95-894e-78b2da220a302026-01-22WarningsExact 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