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
Ingredient	Strength
ZINC OXIDE	4.9 g/100g
TITANIUM DIOXIDE	13.7 g/100g

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67015-2035-0	HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey	10 g in 1 CONTAINER	CREAM	10		4
67015-2035-1	HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey	1 in 1 CARTON	CREAM	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67015-2035	HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 HONEY (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PIERRE FABRE USA INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240131_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 83 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr. C. Tuna Lumi Radiance Brightening	OCTOCRYLENE, OCTINOXATE, AVOBENZONE	Farmasi US LLC	adf5621b-7cf0-53b3-e053-2a95a90a8058	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15	HOMOSALATE, OCTINOXATE	FARMASI US LLC	1dbd5e83-2248-4751-88d9-b446ccc3c61e	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body Sun	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE	Farmasi US LLC	27fdbd2b-60de-4906-a176-5c5198d9925b	2026-01-09	Warnings	Exact identifier application number: M020
Skin Metal Stealth	ZINC OXIDE	Skin Metal	47f5d7de-5d32-041a-e063-6394a90ab6f9	2026-01-09	Warnings	Exact identifier application number: M020
Salt and Blue Body Sunscreen SPF 30	ZINC OXIDE 20%	Salt + Blue LLC	47f764a0-e9ad-ef66-e063-6394a90a8de5	2026-01-09	Warnings	Exact identifier application number: M020
City Sunscreen serum Broad Spectrum SPF 30 Supergoop	HOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENE	Supergoop, LLC	61766f7b-512d-45b5-b652-e09975a3d3fc	2026-01-09	Warnings	Exact identifier application number: M020
Defense Refresh (Re)Setting Mist SPF 40	AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENE	Supergoop LLC	b95ad8e3-978b-b721-e053-2a95a90a1e54	2026-01-09	Warnings	Exact identifier application number: M020
Daily Dose Vitamin C and Broad Spectrum SPF 40 Serum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop LLC	aed0dd03-1695-a5a9-e053-2995a90acfdc	2026-01-09	Warnings	Exact identifier application number: M020
Hand Screen Broad Spectrum Sunscreen SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	972ebab9-3f2f-6716-e053-2a95a90a5c75	2026-01-09	Warnings	Exact identifier application number: M020
Glow Oil Broad Spectrum Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	972c68e7-b137-34c6-e053-2a95a90a77d6	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip Gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ee045b64-7a95-4378-8183-e6e556f3b184	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	967d0657-18fc-4e4a-b52d-442df43329f1	2026-01-09	Warnings	Exact identifier application number: M020
PLAY SPF 30 Lip Shield Coconut	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	b0b8b850-bdfe-5563-e053-2995a90a51a7	2026-01-09	Warnings	Exact identifier application number: M020
Play SPF 30 Lip Shield Strawberry	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	b0a49142-53c3-5b7a-e053-2995a90a581d	2026-01-09	Warnings	Exact identifier application number: M020
Glow Stick Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	61e543e3-9ace-6440-e053-2991aa0a9647	2026-01-09	Warnings	Exact identifier application number: M020
(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35	ZINC OXIDE	Supergoop, LLC	af5c9801-26ce-5c60-e053-2995a90ab457	2026-01-09	Warnings	Exact identifier application number: M020
(Re) Setting 100% mineral Powder Light Broad Spectrum SPF 35	ZINC OXIDE	Supergoop, LLC	aed5a7ef-5cf2-6738-e053-2a95a90aa7f7	2026-01-09	Warnings	Exact identifier application number: M020
Play Mineral Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	89088ac5-f1ee-1996-e053-2a95a90a8fdc	2026-01-09	Warnings	Exact identifier application number: M020
(RE) Setting 100% Mineral Powder Medium Broad Spectrum Sunscreen SPF 35	ZINC OXIDE	Supergoop, LLC	af4b0f17-43ec-a176-e053-2a95a90a7ac6	2026-01-09	Warnings	Exact identifier application number: M020
(Re) Setting 100% mineral Powder Deep Broad Spectrum SPF 35	ZINC OXIDE	Supergoop, LLC	af4cb85b-1275-2105-e053-2995a90a7e74	2026-01-09	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67015-2035-0	67015203500	10 g in 1 CONTAINER	10 g					Historical
67015-2035-1	67015203501	1 CONTAINER in 1 CARTON (67015-2035-1) / 10 g in 1 CONTAINER (67015-2035-0)	1 container	2019-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey	Pierre Fabre USA Inc.	2026-10-01	HUMAN OTC DRUG LABEL	5