Tinted Replenishing Daily Protection

Product NDC: 85377-208
11-digit product format: 853770208
Labeler code: 85377
Product ID: 85377-208_45ffabea-6e6f-930a-e063-6294a90a6df1
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: MANTRA WELLNESS SPA
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-03-31
Substance: ZINC OXIDE
Active strength: 160 mg/g
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: Tinted Replenishing Daily Protection
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	160 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
33898415-4ee6-a384-e063-6394a90ae8e1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85377-208-15	Tinted Replenishing Daily Protection	1.5 g in 1 PACKET	CREAM	1.5		2
85377-208-50	Tinted Replenishing Daily Protection	50 g in 1 BOTTLE, PUMP	CREAM	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85377-208	TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [MANTRA WELLNESS SPA]	1	Current NDC, 1 package rows	20250426_338aa5a2-29e3-fe0e-e063-6294a90a18fd.zip
85377-208	TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [MANTRA WELLNESS SPA]	1	Current NDC, 1 package rows	20250426_33898415-4ee6-a384-e063-6394a90ae8e1.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 183 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Get Your Healthy Glowy Skin Bergamot Glow Primer Blueberry Nutri Tint	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	e375412e-8685-49a2-b1b0-00ab114e14b7	2025-09-12	Warnings	Exact identifier application number: M020
Beach Club Mineral Sunscreen	ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE	R & R Lotion, Inc	d9aae241-229e-4123-abe9-99f74f5ab0b3	2025-09-12	Warnings	Exact identifier application number: M020
sunscreen	TITANIUM DIOXIDE(NANO)	Mingyu (guangdong) Cosmetics Technology Co., Ltd	3e6fe9f3-486b-bba7-e063-6294a90adf37	2025-09-10	Warnings	Exact identifier application number: M020
Zinc Oxide Titanium Oxide	ZINC OXIDE TITANIUM OXIDE	Hello Bello	3e66c234-a152-098e-e063-6394a90ab540	2025-09-10	Warnings	Exact identifier application number: M020
Basin Sun Stick SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Retail Concepts of Minnesota, Inc.	3e78026e-0a6a-9e67-e063-6294a90a1bca	2025-09-10	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 30N Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	428dac83-37dc-4b54-82e9-664f59f9af33	2025-09-10	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 31N Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	3174b962-12c0-43b4-8a9c-56fb044afd66	2025-09-10	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 34W Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	c4135505-f0c5-4a91-91e2-ca0e38a0136c	2025-09-10	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 35W Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	c5f65d27-4ad8-4188-98aa-0d9c2dd36180	2025-09-10	Warnings	Exact identifier application number: M020
Zinc Oxide Titanium Oxide	ZINC OXIDE TITANIUM OXIDE	Hello Bello	3e89d30e-b6cd-fabe-e063-6294a90a30ff	2025-09-10	Warnings	Exact identifier application number: M020
Ocean Potion Suncare 30 Continuous Sunscreen Scent of Sunshine	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GNL BRANDS INTERNATIONAL, LLC	3e60bd44-1984-57c6-e063-6294a90a1f4e	2025-09-09	Warnings	Exact identifier application number: M020
Ocean Potion Suncare 70 Continuous Sunscreen Scent of Sunshine	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GNL BRANDS INTERNATIONAL, LLC	3e60d362-4700-1042-e063-6394a90ab39f	2025-09-09	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 25W Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	3d2a702b-2ff6-473a-9ab1-823e0e53a8cf	2025-09-09	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 29W Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	285c9b63-ae65-4508-8bba-1541b3cc4380	2025-09-09	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 26C Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	733fbb38-1481-415c-8161-18816e87ee4b	2025-09-09	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 28W Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	42d51bd5-0678-4e30-80f7-db10281b9528	2025-09-09	Warnings	Exact identifier application number: M020
Sunglaze Body Gel Cream Sunscreen SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Koco Life LLC	3e6658a1-ae6a-9d19-e063-6294a90acae7	2025-09-09	Warnings	Exact identifier application number: M020
CLARINS Extra Firming Sunscreen SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Laboratoires Clarins	57f07e8a-1043-47e4-9d7b-6e78fdc34119	2025-09-08	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	1d3218e6-8687-4a94-8bf7-3a867920cd1c	2025-09-08	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	6c578ef8-5648-4428-b9a2-0952f9625253	2025-09-08	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85377-208-15	85377020815	1.5 g in 1 PACKET (85377-208-15)	1.5 g	2023-03-31	Yes	No	Current
85377-208-50	85377020850	50 g in 1 BOTTLE, PUMP (85377-208-50)	50 g	2023-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinted Replenishing Daily Protection	MANTRA WELLNESS SPA \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2
Tinted Replenishing Daily Protection	Mantra Wellness Spa \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2