Proper Protection Plus Primer Tinted

Product NDC: 85358-203
11-digit product format: 853580203
Labeler code: 85358
Product ID: 85358-203_460198d2-b59e-3287-e063-6394a90af499
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Skin & Proper LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-15
Substance: ZINC OXIDE; TITANIUM DIOXIDE
Active strength: 38; 80 mg/g; 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: Proper Protection Plus Primer Tinted
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	38 mg/g
TITANIUM DIOXIDE	80 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
15FIX9V2JP	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
359723bb-6152-9566-e063-6294a90a59e0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85358-203-15	Proper Protection Plus Primer Tinted	1.5 g in 1 PACKET	CREAM	1.5		2
85358-203-50	Proper Protection Plus Primer Tinted	53 g in 1 BOTTLE, PUMP	CREAM	53		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85358-203	PROPER PROTECTION PLUS PRIMER TINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN & PROPER LLC]	1	Current NDC, 1 package rows	20250523_359723bb-6152-9566-e063-6294a90a59e0.zip
85358-203	PROPER PROTECTION PLUS PRIMER TINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN & PROPER LLC]	1	Current NDC, 1 package rows	20250523_359782d7-6601-7d96-e063-6394a90af9dc.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 237 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baby Donna SHeer SPF Sunscreen Stick	ZINC OXIDE	Stream2Sea, LLC	a1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe	2025-01-12	Warnings	Exact identifier application number: M020
SUN PROTECT LIP BALM SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Stream2Sea, LLC	21386652-b952-48be-b077-1acecc7f0eb0	2025-01-12	Warnings	Exact identifier application number: M020
Equate Beauty Daily Moisturizer SPF-30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Wal-Mart Stores, Inc.	00abd6d0-c467-4885-80fe-b062622147d7	2025-01-10	Warnings	Exact identifier application number: M020
Bondi Sands SPF 60 Sunny Body	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	2b5aebed-49f6-7bb8-e063-6294a90a8521	2025-01-10	Warnings	Exact identifier application number: M020
Bondi Sands SPF 60 Sunny Drops Face Serum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	2b5c69e4-2819-94ef-e063-6394a90a68e7	2025-01-10	Warnings	Exact identifier application number: M020
Dermaroller Anhydrous Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	04e82f1b-c893-4795-b7a9-0523e3ec7552	2025-01-10	Warnings	Exact identifier application number: M020
Skinfuse Shield SPF 30	ZINC OXIDE	Owen Biosciences, Inc.	b8e4c11a-4b4f-4e36-a75e-0a73913113d5	2025-01-10	Warnings	Exact identifier application number: M020
Correct and Protect Serum Broad Spectrum SPF 45	ZINC OXIDE	Murad, LLC	60c62108-6806-4722-a44b-f1c300d59c1e	2025-01-10	Warnings	Exact identifier application number: M020
Multi Vitamin Clear Coat Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Murad, LLC	e023c874-c89d-4bd0-a0b9-a8161c261457	2025-01-10	Warnings	Exact identifier application number: M020
CoTZ Baby	ZINC OXIDE	Fallien Cosmeceuticals, LTD	17cc12c7-5af8-413f-b205-31ac150583e2	2025-01-09	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	2b3bdbe1-ede9-cd60-e063-6394a90ab2f3	2025-01-09	Warnings	Exact identifier application number: M020
JAFRA ROYAL REVITALIZE 4 TUBE SET	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca98	2025-01-09	Warnings	Exact identifier application number: M020
glo SKIN BEAUTY Moisturizing Tint SPF 30	GLO SKIN BEAUTY MOISTURIZING TINT SPF 30	Hayden Caleel LLC	2b464a70-8f40-3148-e063-6394a90ac18c	2025-01-09	Warnings	Exact identifier application number: M020
Sunscreen and insect repellent Bull frog	SPF 50	Bullfrog Brands, LLC	d65d15a6-0a32-1203-e053-2995a90aa6c5	2025-01-09	Warnings	Exact identifier application number: M020
Sunscreen and insect repellent Bull frog	SPF 50	Bullfrog Brands, LLC	d5fb3632-24da-2c7a-e053-2a95a90a5081	2025-01-09	Warnings	Exact identifier application number: M020
Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	NEW SEASON DERMATOLOGY, PLLC	fecd72a3-c7e5-3dfa-e053-6394a90a7357	2025-01-09	Warnings	Exact identifier application number: M020
ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	41b3cf18-dc11-4e1d-802e-5ba25bd87adb	2025-01-09	Warnings	Exact identifier application number: M020
ECLIPSE SPF 50 PERFECTINT BEIGE	TITANIUM DIOXIDE, ZINC OXIDE	SCIENCE OF SKINCARE LLC	b69dda25-372f-15d9-e053-2995a90a8d3e	2025-01-09	Warnings	Exact identifier application number: M020
PerfecTint Powder SPF 40 All Shades	ZINC OXIDE	Science of Skincare	bb26c010-299e-3dc5-e053-2995a90a2c89	2025-01-09	Warnings	Exact identifier application number: M020
Extreme Protect SPF 40 All Shades	ZINC OXIDE, TITANIUM DIOXIDE	Science of Skincare, LLC.	b69db78b-5f0e-8ca2-e053-2a95a90ac88c	2025-01-09	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	Sample	Exclude flag	Status
85358-203-15	85358020315	1.5 g in 1 PACKET (85358-203-15)	1.5 g	2024-07-15	Yes	No	Current
85358-203-50	85358020350	53 g in 1 BOTTLE, PUMP (85358-203-50)	53 g	2024-07-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Proper Protection Plus Primer Tinted	Skin & Proper LLC \| Custom Analytics LLC \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2
Proper Protection Plus Primer Tinted	Skin & Proper LLC \| Custom Analytics LLC \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2