SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen

Product NDC: 49967-077
11-digit product format: 499670077
Labeler code: 49967
Product ID: 49967-077_b9c31cda-e772-40f8-9d6b-9933ec4605ef
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: L'Oreal USA Products Inc
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-01-01
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 60; 50 mg/mL; mg/mL
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: SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	60 mg/mL
ZINC OXIDE	50 mg/mL

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
8df98d97-a5d2-4d52-8bd2-130a13501d60	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49967-077-01	SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen	1 in 1 CARTON	LOTION	1	12
49967-077-01	SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen	50 mL in 1 BOTTLE	LOTION	50	12
49967-077-02	SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen	4 mL in 1 TUBE	LOTION	4	12
49967-077-03	SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen	125 mL in 1 BOTTLE	LOTION	125	12
49967-077-04	SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen	250 mL in 1 BOTTLE	LOTION	250	12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]	4
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]	4
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]	4
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	SKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49967-077	SKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]	12	Current NDC, Legacy NDC, 5 package rows	20240717_8df98d97-a5d2-4d52-8bd2-130a13501d60.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 243 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15	OCTINOXATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	d9209277-469d-48f4-bf64-f39a70c19596	2024-12-31	Warnings	Exact identifier application number: M020
Almay Smart Shade Skintone Matching Makeup Light	TITANIUM DIOXIDE ZINC OXIDE	Almay, Inc.	2a987b85-efdb-eb95-e063-6394a90aef81	2024-12-31	Warnings	Exact identifier application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Light	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a984dd9-7293-77f0-e063-6294a90a8f1e	2024-12-31	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	097fc15e-ea17-47b2-9581-19c5e11592f6	2024-12-30	Warnings	Exact identifier application number: M020
HERBAL UV DEFENSE SPF40	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	COSMAX USA, CORPORATION	2a76fd94-2f1f-e6d8-e063-6294a90a287c	2024-12-30	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	ab20969a-8640-307d-e053-2a95a90a004d	2024-12-30	Warnings	Exact identifier application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS	OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE	Exelencia importers Corp.	2a845e4c-86e7-1799-e063-6294a90a9b2b	2024-12-30	Warnings	Exact identifier application number: M020
American Crew All In One Face Balm Broad Spectrum SPF 15	OCTISALATE,HOMOSALATE,AVOBENZONE,OCTOCRYLENE	Revlon Consumer Products Corp	012be422-1b4c-443c-9484-02efc744296d	2024-12-30	Warnings	Exact identifier application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	REVLON	2a857553-5ad0-a0e2-e063-6294a90af435	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2035ab03-80b4-49f4-b379-eb8bc42c9cee	2024-12-30	Warnings	Exact identifier application number: M020
PRISMA PROTECT SPF30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	713bad2e-bf32-4cd5-9630-b8d88d437686	2024-12-30	Warnings	Exact identifier application number: M020
Protection 50 Sport	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	e9ace96a-7717-4f5a-8e1b-1f56f7498599	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	b137b3d0-212b-440a-b158-62ace4b4eff3	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	3a6db7d3-6c59-4633-a97e-1c03127246d3	2024-12-30	Warnings	Exact identifier application number: M020
Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen	OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	df62e1c2-ce72-4ded-8985-156dce9ff41d	2024-12-28	Warnings	Exact identifier application number: M020
LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	02dddfc5-61e6-433b-8d6d-a17bf3fc8ed6	2024-12-28	Warnings	Exact identifier application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	229eef79-39ae-4395-8100-64d1ece960d2	2024-12-28	Warnings	Exact identifier application number: M020
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

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	Marketing end	Sample	Exclude flag	Status
49967-077-01	49967007701	1 BOTTLE in 1 CARTON (49967-077-01) / 50 mL in 1 BOTTLE	1 bottle	2011-01-01	0000-00-00	No	No	Current
49967-077-02	49967007702	4 mL in 1 TUBE (49967-077-02)	4 ml	2011-01-01	0000-00-00	No	No	Current
49967-077-03	49967007703	125 mL in 1 BOTTLE (49967-077-03)	125 ml	2011-01-01	0000-00-00	No	No	Current
49967-077-04	49967007704	250 mL in 1 BOTTLE (49967-077-04)	250 ml	2011-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	L'Oreal USA Products Inc \| Goodier Cosmetics LP \| Beauty Manufacturing Solutions Corp.	2024-07-16	HUMAN OTC DRUG LABEL	12