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 237 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Earths Daughter Vanilla Bean SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad0db95-a283-3c91-e063-6294a90ae5232025-01-03WarningsExact identifier
application number: M020
Earths Daughter Strawberry Breeze SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad129b7-4ecd-a967-e063-6294a90ad8c42025-01-03WarningsExact identifier
application number: M020
Earths Daughter Citrus Blast SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad18f4b-4251-be82-e063-6394a90acac52025-01-03WarningsExact identifier
application number: M020
Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad1bb50-869e-8122-e063-6294a90ac7242025-01-03WarningsExact identifier
application number: M020
Glow Baby Brightening Setting Mist SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPacifica Beauty, LLCf2f53cf9-3717-07ff-e053-2a95a90a03fb2025-01-03WarningsExact identifier
application number: M020
Future Youth Daily Turnaround Hydrating Moisturizer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEPacifica Beauty, LLC0324275f-13bc-e7b8-e063-6294a90a69022025-01-03WarningsExact identifier
application number: M020
Glow Baby Super Lit SPF 30ZINC OXIDEPacifica Beauty, LLCf3d3eee2-a5d9-113b-e053-2995a90a70572025-01-03WarningsExact identifier
application number: M020
Kind Tint SPF 30ZINC OXIDEPacifica Beauty, LLCf421cbf7-cfae-5eae-e053-2995a90ab35c2025-01-03WarningsExact identifier
application number: M020
Vegan Collagen Every Day SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEPacifica Beauty, LLCf449da32-5ade-2c78-e053-2a95a90a27a12025-01-03WarningsExact identifier
application number: M020
Members Mark SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESam's West Inc2b354ab6-f241-676f-e063-6394a90a58932025-01-03WarningsExact identifier
application number: M020
Vanilla Mint Lip BalmLIP BALMCasad Company Inc.3214bff3-e133-43ca-946d-f4c5dd0747602025-01-03WarningsExact identifier
application number: M020
Vanilla Lip BalmLIP BALMCasad Company Inc.d27398d3-98b0-4f70-997e-6ed02559594f2025-01-03WarningsExact identifier
application number: M020
Cherry Lip BalmLIP BALMCasad Company Inc.b262645e-f069-420d-90ac-9eb4b82236d82025-01-03WarningsExact identifier
application number: M020
Peppermint Lip BalmLIP BALMCasad Company Inc.46a4b6d1-37e4-471d-a41b-57afe8bd9f2f2025-01-03WarningsExact identifier
application number: M020
Beeswax Lip BalmLIP BALMCasad Company Inc.5301398d-82f8-495e-b3ec-0938eca163692025-01-03WarningsExact identifier
application number: M020
Spearmint Lip BalmLIP BALMCasad Company Inc.ba9b5420-60b0-4528-9898-a0a5287a2aee2025-01-03WarningsExact identifier
application number: M020
Pomegranate Lip BalmLIP BALMCasad Company Inc.4e943a8a-f627-4e28-bdd7-c2b63be5dca32025-01-03WarningsExact identifier
application number: M020
Tropical Lip BalmLIP BALMCasad Company Inc.5e730d21-b810-4b84-9c85-0343ab0c8d5a2025-01-03WarningsExact identifier
application number: M020
Green Defense Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEFarmacy Beauty LLCadf0f50f-6357-bc1f-e053-2a95a90ad9972025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 BambooZINC OXIDEEVER FAME PTE. LTD.2abbc7fb-ea5d-9c68-e063-6394a90a88d22025-01-02WarningsExact 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