FDA.reportPublic FDA data

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
IngredientStrength
TITANIUM DIOXIDE60 mg/mL
ZINC OXIDE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8df98d97-a5d2-4d52-8bd2-130a13501d60Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-077-01SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen1 in 1 CARTONLOTION112
49967-077-01SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen50 mL in 1 BOTTLELOTION5012
49967-077-02SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen4 mL in 1 TUBELOTION412
49967-077-03SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen125 mL in 1 BOTTLELOTION12512
49967-077-04SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen250 mL in 1 BOTTLELOTION25012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]4
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]4
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]4
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSKINCEUTICALS 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
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-077SKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]12Current NDC, Legacy NDC, 5 package rows20240717_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 15 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bath and Body Works SPF CoconutAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.56078491-f7d6-97f7-e063-6394a90a6deb2026-07-07WarningsExact identifier
application number: M020
Natu Botanicals DAILY NATURAL SUNSCREEN SPF 35 Reef safe mineral sunscreen with non-nano zinc oxideZINC OXIDESurprise Enterprise LLC38cf4325-9720-f511-e063-6394a90ad6282026-07-07WarningsExact identifier
application number: M020
Sun Bum Road Tripper - Amazon - Coconut Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC560c0f35-2132-52a6-e063-6394a90a2d242026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 BonnieCIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIEDelicate Cosmetics Inc560d1d19-87a6-179b-e063-6294a90ada5e2026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 KellyCIELE LIP AND PROTECT LIPSTICK SPF 60 KELLYDelicate Cosmetics Inc560df34a-e6da-0792-e063-6394a90a7e712026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 LouLouCIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOUDelicate Cosmetics Inc560e37ae-87c0-39d2-e063-6394a90a2af42026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 CassetteCIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTEDelicate Cosmetics Inc560e4198-b07c-3d48-e063-6394a90a7be32026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 MargauxCIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUXDelicate Cosmetics Inc560e47d5-c881-438c-e063-6394a90a30912026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 SaddleCIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLEDelicate Cosmetics Inc560e5de5-1350-4046-e063-6394a90abffa2026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 PuzzleCIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLEDelicate Cosmetics Inc560e5558-8e46-7736-e063-6294a90acb052026-07-07WarningsExact identifier
application number: M020
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
application number: M020
Sunscreen SPF 50AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Products1d4be26a-4695-491c-85d1-86824e1cd0292026-07-06WarningsExact identifier
application number: M020
SPF 30 SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLC71856cb3-9386-4569-80e4-92826342e3862026-07-06WarningsExact identifier
application number: M020
Stay Ageless SunscreenBROAD SPECTRUM SPF 30TOXFAIRY, LLC55f7e07e-1689-6d38-e063-6294a90a91192026-07-06WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
application number: M020
RR SunHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEUndefined Inc87244432-2967-4145-89cd-11a7567083a32026-07-06WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.35af90d3-dfe1-30dc-e063-6294a90a10a52026-07-05WarningsExact identifier
application number: M020
MDP PEPTIDE 9 BIO SUN PROHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANESKINIDEA CO., LTD26db53cd-dd82-8790-e063-6394a90a92b12026-07-03WarningsExact identifier
application number: M020
SPF 50 plus SunscreenTITANIUM DIOXIDE AND ZINC OXIDETheravita LLCd8e276cc-0292-499d-9075-a83a2d3fafcc2026-07-02WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.5880b275-91fc-4589-a076-0e55409425d82026-07-02Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-077-01499670077011 BOTTLE in 1 CARTON (49967-077-01) / 50 mL in 1 BOTTLE1 bottle2011-01-010000-00-00NoNoCurrent
49967-077-02499670077024 mL in 1 TUBE (49967-077-02) 4 ml2011-01-010000-00-00NoNoCurrent
49967-077-0349967007703125 mL in 1 BOTTLE (49967-077-03) 125 ml2011-01-010000-00-00NoNoCurrent
49967-077-0449967007704250 mL in 1 BOTTLE (49967-077-04) 250 ml2011-01-010000-00-00NoNoCurrent