Tinted Replenishing Daily Protection

Product NDC: 85679-208
11-digit product format: 856790208
Labeler code: 85679
Product ID: 85679-208_4600ca1a-bf57-40de-e063-6394a90af359
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: HELTON SKIN & LASER INSTITUTE
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-02-22
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
35a9d07d-70e5-5eed-e063-6394a90aebaf	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85679-208-50	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
85679-208	TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [HELTON SKIN & LASER INSTITUTE]	1	Current NDC, 1 package rows	20250523_35a9d07d-70e5-5eed-e063-6394a90aebaf.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 253 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SABLE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29a8812b-70ff-e8aa-e063-6294a90a09f8	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Neutral Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE	KW ABSC, INC.	3a548deb-3670-4c5b-a139-796701801fed	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Olive Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	be4434c0-cbdd-46cb-8015-4c7859e80d4a	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Golden Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	de50e956-a014-4147-922b-63c95fa6f86b	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Neutral Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	44cbb226-83ed-401b-baf8-ca8e4740dbef	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Neutral Medium Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	615f5e39-695d-41d4-af59-e0d3b76789bb	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Warm Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE	KW ABSC, INC.	6ab3e360-8104-4439-93fb-e11bc4a77558	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Neutral Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	a297ff64-678c-4936-8384-022606a2f33c	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Neutral Fair	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a2	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Cool Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	2e0365f9-d3c6-4404-90ac-772a829b3ade	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18- D2 NUTMEG	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29abae8f-53db-b592-e063-6294a90adabb	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 MOCHA	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29aba80c-55b7-b8d9-e063-6294a90a5cc1	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 COCOA	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29abe97b-e9b3-6e27-e063-6294a90ae3ed	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 DEEP GOLDEN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29abdf3c-fb54-a5e3-e063-6394a90af450	2024-12-19	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM FAIR	ZINC OXIDE	COSMAX USA, CORPORATION	29ac756b-3df7-50c9-e063-6394a90aa479	2024-12-19	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM RICH	ZINC OXIDE	COSMAX USA, CORPORATION	29ac51a0-07e7-ad7b-e063-6294a90ae777	2024-12-19	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM DEEPEST	ZINC OXIDE	COSMAX USA, CORPORATION	29ad12e2-0a2e-7138-e063-6394a90aebaf	2024-12-19	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Face Sheer Tint Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products, Inc.	f2e34230-7bfb-455f-8b33-6bff96fd9f0a	2024-12-19	Warnings	Exact identifier application number: M020
Anew Platinum DayCream Broad Spectrum SPF 25	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	COSMAX USA, CORPORATION	56200212-bedc-6e1e-e063-6394a90a3666	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELL	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29868d60-b900-e0ad-e063-6294a90af87a	2024-12-18	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
85679-208-50	85679020850	50 g in 1 BOTTLE, PUMP (85679-208-50)	50 g	2024-02-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinted Replenishing Daily Protection	HELTON SKIN & LASER INSTITUTE \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2