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 129 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Canopy SPF 40 Tinted	ZINC OXIDE	BORREGO SPRINGS SKINCARE LLC	358319c5-ae35-cb3b-e063-6394a90ad77f	2025-12-12	Exact identifier application number: M020
Non-Tinted Matte Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Philosophy by Kelly	3581ab49-ef55-3743-e063-6394a90a3bd5	2025-12-12	Exact identifier application number: M020
Matte Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Philosophy by Kelly	3581cf33-3520-42f7-e063-6394a90a6f93	2025-12-12	Exact identifier application number: M020
Mineral Sunscreen For Face and Body	ZINC OXIDE	Skin Philosophy by Kelly	358248e6-16cf-6f9b-e063-6394a90a55d7	2025-12-12	Exact identifier application number: M020
Replenishing Mineral Sunscreen	ZINC OXIDE	Skin Philosophy by Kelly	35828e76-66db-49de-e063-6294a90a2b99	2025-12-12	Exact identifier application number: M020
Matte Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Philosophy by Kelly	3592b2c7-295a-7c60-e063-6394a90a387b	2025-12-12	Exact identifier application number: M020
Mineral Sunscreen For Face and Body	ZINC OXIDE	Skin Philosophy by Kelly	3592fd5f-13d1-9aec-e063-6394a90abd67	2025-12-12	Exact identifier application number: M020
Replenishing Mineral Sunscreen	ZINC OXIDE	Skin Philosophy by Kelly	359371f2-2407-e1a1-e063-6294a90a2165	2025-12-12	Exact identifier application number: M020
Non Tinted Sheer Mineral Zinc Sunscreen	ZINC OXIDE	SKIN THERAPY PLLC	397fc3c9-9d30-adcf-e063-6394a90ac761	2025-12-12	Exact identifier application number: M020
Non Tinted Sheer Mineral Zinc Sunscreen	ZINC OXIDE	SKIN THERAPY PLLC	39800bf1-e01a-e1c8-e063-6294a90a53bf	2025-12-12	Exact identifier application number: M020
Tinted Sheer Mineral Zinc Sunscreen	ZINC OXIDE	SKIN THERAPY PLLC	397130ea-dfad-ecd3-e063-6394a90a7da4	2025-12-12	Exact identifier application number: M020
Tinted Sheer Mineral Zinc Sunscreen	ZINC OXIDE	SKIN THERAPY PLLC	39716532-a699-63b7-e063-6294a90aa0f0	2025-12-12	Exact identifier application number: M020
Sun Elegant Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	SKIN BY NESRIN	3580ae10-1867-cb68-e063-6394a90a72df	2025-12-12	Exact identifier application number: M020
Simply Zinc Mineral Sunscreen Tinted	ZINC OXIDE	SKIN BY NESRIN	3580da4f-116d-8108-e063-6294a90a7bf4	2025-12-12	Exact identifier application number: M020
PROTECTOR SOLAR NON-TINTED SPF SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	The Beez Kneez Skin Care & Acne Clinic LLC	358195c0-6d28-1ffe-e063-6394a90a6027	2025-12-12	Exact identifier application number: M020
PROTECTOR SOLAR TINTED SPF SUNSCREEN	ZINC OXIDE	The Beez Kneez Skin Care & Acne Clinic LLC	3581d973-ac0b-7d2e-e063-6294a90ae2b3	2025-12-12	Exact identifier application number: M020
Matte Velvet Tint	TITANIUM DIOXIDE, ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	3583f860-664b-2658-e063-6394a90a3857	2025-12-12	Exact identifier application number: M020
Satin Tint	ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	35920108-7f8a-27d4-e063-6294a90a0ef6	2025-12-12	Exact identifier application number: M020
SPF Lip	TITANIUM DIOXIDE, ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	359297cd-10e2-6ddd-e063-6394a90a4aa0	2025-12-12	Exact identifier application number: M020
Matte Velvet Tint	TITANIUM DIOXIDE, ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	359641c5-0e19-f243-e063-6394a90aeebc	2025-12-12	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