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 147 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Based Foam Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32465271-abb9-d03f-e063-6294a90a990e	2025-12-08		Exact identifier application number: M020
Mineral Based Foam Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32486bfb-0cc8-0283-e063-6394a90a9967	2025-12-08		Exact identifier application number: M020
Harrys Daily Facial SPF Broad Spectrum	ZINC OXIDE	Harry's, Inc.	39fdde34-45ec-bc22-e063-6394a90a7dce	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen Brightening plus Tint	ZINC OXIDE	ZEN DERMATOLOGY, INC.	31e32e9c-9e0b-b678-e063-6294a90a66f5	2025-12-08		Exact identifier application number: M020
Healthy Mineral Sunscreen No Shine plus Tint	ZINC OXIDE	Zen Dermatology, Inc.	31576340-cb11-d944-e063-6294a90adef2	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen No Shine - No Tint	TITANIUM DIOXIDE, ZINC OXIDE	Zen Dermatology, Inc.	31572a16-5f60-565f-e063-6394a90ab8c9	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen Face and Body	ZINC OXIDE	Zen Dermatology, Inc.	31e376b4-098f-34d7-e063-6394a90a1772	2025-12-08		Exact identifier application number: M020
AcneFix Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ACNEFIX INC.	315894b7-ac1b-0982-e063-6294a90ab879	2025-12-08		Exact identifier application number: M020
Shunly Natural Cover SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Shunly Skin Care	a64e373b-b3f6-4024-b5f5-253783485cd6	2025-12-08	Warnings	Exact identifier application number: M020
AcneFix Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ACNEFIX INC.	31583c7e-365a-d899-e063-6394a90aa63f	2025-12-08		Exact identifier application number: M020
Mineral Fusion Tinted	TITANIUM DIOXIDE, ZINC OXIDE	FOREFRONT DERMATOLOGY, S.C.	334ec844-5560-50f7-e063-6394a90a01be	2025-12-08		Exact identifier application number: M020
Mineral Fusion Tinted	TITANIUM DIOXIDE, ZINC OXIDE	FOREFRONT DERMATOLOGY, S.C.	334f90d6-68e5-db37-e063-6294a90a5fb1	2025-12-08		Exact identifier application number: M020
Skin Apeel Pure Protect SPF 40 Broad Spectrum	ZINC OXIDE	Skin Apeel, Inc.	18e78c7f-1523-a4f4-e063-6394a90aed97	2025-12-08	Warnings	Exact identifier application number: M020
Silk Screen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c44baf4-9555-faad-e063-6294a90ab24f	2025-12-08	Warnings	Exact identifier application number: M020
Glow Stick	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c54b857-c017-a953-e063-6394a90a38df	2025-12-08	Warnings	Exact identifier application number: M020
Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c545e55-3f55-842b-e063-6394a90ae48e	2025-12-08	Warnings	Exact identifier application number: M020
Bare Barrier Sport	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c580794-eda3-de57-e063-6294a90a0303	2025-12-08	Warnings	Exact identifier application number: M020
Flawless Brightening Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Flawless Skin Care LLC	312e9ca0-a388-a546-e063-6294a90a15d6	2025-12-08	Warnings	Exact identifier application number: M020
Mineral SPF 40, protect	TITANIUM DIOXIDE, ZINC OXIDE	Acne Specialists LLC	2f8859cf-8277-6ea9-e063-6294a90a1a75	2025-12-08	Warnings	Exact identifier application number: M020
Mineral SPF 40, Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Acne Specialists LLC	2fb19ed7-8cee-ce80-e063-6394a90ad3dc	2025-12-08	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