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: 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: Complexion Correction Tinted Primer Sunscreen
Listing expiration: 2027-12-31

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 273 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hawaiian Tropic	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	77cdd346-d273-ed66-e053-2991aa0ae31d	2024-10-31	Warnings	Exact identifier application number: M020
Hawaiian Tropic	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	767accea-c5b2-32dc-e053-2991aa0a3338	2024-10-31	Warnings	Exact identifier application number: M020
ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50	ZINC OXIDE	ZO Skin Health, Inc.	f218c158-19aa-ab90-e053-2a95a90aaef3	2024-10-31	Warnings	Exact identifier application number: M020
Banana Boat	ZINC OXIDE	Edgewell Personal Care Brands LLC	1ce728be-966e-b662-e063-6394a90a0ba8	2024-10-30	Warnings	Exact identifier application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	COSMAX USA, INC.	2596a17e-4042-3544-e063-6294a90aa4c9	2024-10-29	Warnings	Exact identifier application number: M020
Sunblocz	ZINC OXIDE	Olen Skin Care Corporation	36fec1f1-5e8b-5764-e054-00144ff8d46c	2024-10-29	Warnings	Exact identifier application number: M020
Sunblocz Baby and Kids	ZINC OXIDE	Olen Skin Care Corporation	35cbb9d5-639c-207a-e054-00144ff88e88	2024-10-29	Warnings	Exact identifier application number: M020
ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ZO Skin Health, Inc.	fd7d40fe-178a-e1b1-e053-6294a90a29a1	2024-10-29	Warnings	Exact identifier application number: M020
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	ZO Skin Health, Inc.	9a4f5be1-da04-48b9-897a-57f4a3d9d1ec	2024-10-29	Warnings	Exact identifier application number: M020
TiZO Ultra Zinc SPF 40 (Non-Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	e4a06973-21bb-4eda-9b74-fc23bee141ab	2024-10-29	Warnings	Exact identifier application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	36efd48b-910e-4b61-9519-a6d5c7e9a7c3	2024-10-29	Warnings	Exact identifier application number: M020
ZO Skin Health Broad-Spectrum Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health, Inc.	d817f80b-a998-b67e-e053-2995a90a1971	2024-10-29	Warnings	Exact identifier application number: M020
SPF 15 Coconut Lip Balm	ZINC OXIDE	Naples Soap Company, Inc.	25a7510f-5ef3-9920-e063-6394a90a2079	2024-10-29	Warnings	Exact identifier application number: M020
Defense Total High Protection SPF 50 No Color Daily Non-Greasy Face Protection	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	Bel Star S.A. (Colombia)	a7d69691-cecc-798e-e053-2a95a90a995f	2024-10-28	Warnings	Exact identifier application number: M020
LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F	OCTINOXATE, ZINC OXIDE	Bel Star S.A.	eea17271-e8c8-ab21-e053-2995a90a2fcc	2024-10-28	Warnings	Exact identifier application number: M020
LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BEL STAR SA	fd90ffc6-a1e1-e02e-e053-6294a90a4e7c	2024-10-28	Warnings	Exact identifier application number: M020
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	0b782198-58e7-5343-e063-6294a90a3713	2024-10-28	Warnings	Exact identifier application number: M020
FHF Elevated Shade 100% Mineral Sunscreen	SUNSCREEN	Owen Biosciences Inc	dabd3b95-01d3-014c-e053-2a95a90a0fec	2024-10-28	Warnings	Exact identifier application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BAY BELLE LABS	259653e7-dfe0-44a2-e063-6294a90a416d	2024-10-28	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	8a21acbe-2f3d-cf78-e053-2a95a90a77f6	2024-10-27	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