Complexion Correction Tinted Primer Sunscreen

Product NDC: 85449-203
11-digit product format: 854490203
Labeler code: 85449
Product ID: 85449-203_46009574-d84f-fac5-e063-6394a90a4ce3
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-11-08
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 80; 38 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Complexion Correction Tinted Primer Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
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
357f2f62-904a-2234-e063-6394a90aee72	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85449-203-15	Complexion Correction Tinted Primer Sunscreen	1.5 g in 1 PACKET	CREAM	1.5		2
85449-203-50	Complexion Correction Tinted Primer Sunscreen	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
85449-203	COMPLEXION CORRECTION TINTED PRIMER SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY]	1	Current NDC, 1 package rows	20250521_357f2f62-904a-2234-e063-6394a90aee72.zip
85449-203	COMPLEXION CORRECTION TINTED PRIMER SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY]	1	Current NDC, 1 package rows	20250521_358021a2-235b-825b-e063-6394a90a76f5.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 248 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOLA Mineral Sun Silk Creme Sunscreen SPF 30	ZINC OXIDE	COOLA LLC	bb9dd9a9-ec01-4e94-9172-3a72e68a417a	2024-12-27	Warnings	Exact identifier application number: M020
Bare Republic Mineral SPF 50	ZINC OXIDE	COOLA LLC	6a0db9da-ee45-4ab7-80de-4bf189efe75f	2024-12-27	Warnings	Exact identifier application number: M020
COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum SPF 50	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	COOLA LLC	9a397a2c-4734-4dae-93dd-15c68e6c297d	2024-12-27	Warnings	Exact identifier application number: M020
Refreshing Water Hydration Stick SPF 50	AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENE	COOLA LLC	6da037f8-bedb-467a-b534-e44752120f2c	2024-12-27	Warnings	Exact identifier application number: M020
Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	NSE Products, Inc.	649a9c28-bfd4-404c-90d5-5d0ea8c7b645	2024-12-27	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	87496037-36ca-4c5f-973f-46626cf4096e	2024-12-27	Warnings	Exact identifier application number: M020
PORESCREEN SPF40	ZINC OXIDE	Dermalogica, LLC.	37a7362a-b251-4d3a-a957-65d8f338fa12	2024-12-27	Warnings	Exact identifier application number: M020
COOLA Classic Face Sunscreen Fragrance-Free SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	12ff4689-f7e2-49db-8848-608c61b41ef0	2024-12-27	Warnings	Exact identifier application number: M020
NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT	ZINC OXIDE	Bentley Laboratories, LLC	6edd51e5-1c42-4e66-b5ca-abfea2dad8f8	2024-12-27	Warnings	Exact identifier application number: M020
Tone Control Morning Cream SPF 15	OCTOCRYLENE AND OCTISALATE CREAM	Bentley Laboratories, LLC	b4e3cd1c-ae42-4995-a314-96d24d328e41	2024-12-27	Warnings	Exact identifier application number: M020
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)	ZINC OXIDE	ZO Skin Health, Inc.	be25489e-c3bf-77c5-e053-2a95a90a30de	2024-12-27	Warnings	Exact identifier application number: M020
COOLA Classic Body Sunscreen Tropical Coconut SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	55ad5d2f-a855-491e-a287-13689f8abff1	2024-12-27	Warnings	Exact identifier application number: M020
RODAN and FIELDS UNBLEMISH	TITANIUM DIOXIDE, ZINC OXIDE	Bentley Laboratories, LLC	2b3b6b62-364f-4aba-8024-3a73752b4c56	2024-12-27	Warnings	Exact identifier application number: M020
Powerbright Moisturizer SPF 50	OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATE	Dermalogica, LLC.	02c731ee-c5cb-4158-9b1f-e826593c3526	2024-12-27	Warnings	Exact identifier application number: M020
INVISIBLE PHYSICAL DEFENSE SPF30	ZINC OXIDE	Dermalogica, Inc.	2e5e6861-25ea-4605-8e59-41d852c002b7	2024-12-27	Warnings	Exact identifier application number: M020
COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	COOLA LLC	dec3b0d1-f06e-4acf-8ba2-64167e774abc	2024-12-27	Warnings	Exact identifier application number: M020
Clearing Defense SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Dermalogica, Inc.	2388ae53-0a61-43c0-8936-c639887a5649	2024-12-26	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c5efde-42e3-e4fc-e063-6394a90a491d	2024-12-26	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c62206-d832-8d9a-e063-6394a90a4c69	2024-12-26	Warnings	Exact identifier application number: M020
Morphe SPF 30 Broad Spectrum Sunsetter Setting	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	COSMAX USA, CORPORATION	0d34406f-9dd0-3909-e063-6394a90ab9f9	2024-12-26	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
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
85449-203-15	85449020315	1.5 g in 1 PACKET (85449-203-15)	1.5 g	2024-10-23	Yes	No	Current
85449-203-50	85449020350	53 g in 1 BOTTLE, PUMP (85449-203-50)	53 g	2023-11-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Complexion Correction Tinted Primer Sunscreen	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY \| Custom Analytics LLC \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2
Complexion Correction Tinted Primer Sunscreen	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY \| Custom Analytics LLC \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2