FDA.reportPublic FDA data

SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen

Manufacturer
L'Oreal USA Products Inc | Goodier Cosmetics LP | Beauty Manufacturing Solutions Corp.
Effective date
2024-07-16
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 00:15:22

Label at a glance#

ProductSkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 sections

Indications and uses

- helps prevent sunburn - if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

● apply liberally 15 minutes before sun exposure ● reapply:     ● after 40 minutes of swimming or sweating     ● immediately after towel drying     ● at least every 2 hours ● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk,     regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures ...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 6%

Zinc oxide 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

● apply liberally 15 minutes before sun exposure

● reapply:

    ● after 40 minutes of swimming or sweating

    ● immediately after towel drying

    ● at least every 2 hours

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk,

    regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

   ● limit time in the sun, especially from 10 a.m. – 2 p.m.

   ● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, dimethicone, isododecane, c12-15 alkyl benzoate, undecane, triethylhexanoin, isohexadecane, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, styrene/acrylates copolymer, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, caprylyl glycol, iron oxides, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, tocopherol, propylene carbonate, artemia extract, benzoic acid, PEG-9, disodium stearoyl glutamate, aluminum hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton
image of a carton
image of a carton

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP4
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z4
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP4
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-07749967-077-01, 49967-077-02, 49967-077-03, 49967-077-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
ISODODECANEA8289P68Y2IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
UNDECANEJV0QT00NUEIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
ISOHEXADECANE918X1OUF1EIACT
NYLON-12446U8J075BIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PHENETHYL BENZOATE0C143929GKIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIDECANEA3LZF0L939IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
DICAPRYLYL ETHER77JZM5516ZIACT
TALC7SEV7J4R1UIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
PENTYLENE GLYCOL50C1307PZGIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
ALUMINUM OXIDELMI26O6933IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
CAPRYLYL GLYCOL00YIU5438UIACT
FERRIC OXIDE RED1K09F3G675IACT
PEG-8 LAURATE762O8IWA10IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TOCOPHEROLR0ZB2556P8IACT
PROPYLENE CARBONATE8D08K3S51EIACT
BENZOIC ACID8SKN0B0MIMIACT
POLYETHYLENE GLYCOL 4505IRA46LB71IACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8df98d97-a5d2-4d52-8bd2-130a13501d602024-07-16WarningsExact identifier
ndc (package): 49967-077-03
ndc (package): 49967-077-02
ndc (package): 49967-077-01
ndc (package): 49967-077-04
ndc (product): 49967-077
ndc11 (package): 49967007703
ndc11 (package): 49967007704
ndc11 (package): 49967007701
ndc11 (package): 49967007702
spl id: b9c31cda-e772-40f8-9d6b-9933ec4605ef
spl set id: 8df98d97-a5d2-4d52-8bd2-130a13501d60

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.