FDA.reportPublic FDA data

OCTINOXATE, TITANIUM DIOXIDE

Manufacturer
LVMH Fragrance Brands
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:22:01

Label at a glance#

ProductGivenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Gold
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure8 sections

Dosage and administration

■ Apply liberally 15 minutes before sun exposure. ■ Reapply at least every 2 hours. ■ Use a water resistant sunscreen if swimming or sweating. ■ 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 of 15 or higher and other sun protection measures including:     ■ limit time in the sun, ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.996%

Titanium Dioxide 2.19%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

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.

For external use only

WARNINGS SECTION

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

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ Apply liberally 15 minutes before sun exposure. ■ Reapply at least every 2 hours. ■ Use a water resistant sunscreen if swimming or sweating. ■ 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 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-sleeve shirts, pants, hats, and sunglasses ■ Children under 6 months of age: ask a doctor.








Other Information

SPL UNCLASSIFIED SECTION

■ Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Butylene Glycol, PEG-9 Polydimethylsiloxyethyl Dimethicone, Phenyl Trimethicone, Alcohol, Saccharide Isomerate, Polymethylsilsesquioxane, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Sorbitan Sesquioleate, Aluminum Hydroxide, Dimethicone, Sodium Myristoyl Glutamate, Stearic Acid, Disteardimonium Hectorite, Tocopheryl Acetate, Pentylene Glycol, Jasminum Officinale (Jasmine) Flower Extract, Fragrance, Propylene Carbonate, Tromethamine, Citric Acid, Sodium Citrate, Butylphenyl Methylpropional, Diamond Powder, BHT, Geraniol, Tocopherol, Titanium Dioxide, Iron Oxides.

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxLabelBoxLabelShade6Shade6

Sample Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nude GoldNude Gold

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN01
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV691
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIAMONDINACTIVE INGREDIENT6GRV67N0U21
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09L1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
GERANIOLINACTIVE INGREDIENTL837108USY1
JASMINUM OFFICINALE FLOWERINACTIVE INGREDIENT0Q8K8414321
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEINACTIVE INGREDIENTTYP81E471F1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R1
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51E1
SACCHARIDE ISOMERATEINACTIVE INGREDIENTW8K377W98I1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SODIUM MYRISTOYL GLUTAMATEINACTIVE INGREDIENTAYU7QD893W1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5A1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2V1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60905-004560905-0045-1, 60905-0045-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
ALCOHOL3K9958V90MIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
STEARIC ACID4ELV7Z65APIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PENTYLENE GLYCOL50C1307PZGIACT
JASMINUM OFFICINALE FLOWER0Q8K841432IACT
PROPYLENE CARBONATE8D08K3S51EIACT
TROMETHAMINE023C2WHX2VIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
DIAMOND6GRV67N0U2IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
GERANIOLL837108USYIACT
TOCOPHEROLR0ZB2556P8IACT
FERRIC OXIDE RED1K09F3G675IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 280 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, EXTENDED RELEASE / ORAL0.03 mgExact identifier — unii candidate
32 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / AURICULAR (OTIC)0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / RESPIRATORY (INHALATION)0.01 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / SUBLINGUAL24 mgExact identifier — unii candidate
88 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / BUCCAL0.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VINJECTION, SOLUTION / INTRAMUSCULAR1.21 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / URETHRAL0.12 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / RESPIRATORY (INHALATION)8 mgExact identifier — unii candidate
88 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE CARBONATEPROPYLENE CARBONATE8D08K3S51EOINTMENT / TOPICAL3000 mgExact identifier — unii candidate
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VINJECTION / INTRAMUSCULAR437 mgExact identifier — unii candidate
28 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VINJECTION / INTRA-ARTERIAL562 mgExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VTABLET / ORAL30 mgExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VINJECTION, SOLUTION / INTRA-ARTERIAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE / ORAL238 mgExact identifier — unii candidate
88 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates

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
252741b6-9eb3-a8aa-e063-6394a90a286fe3ac8a17-8483-4814-b36e-c1ad41e4b20c2024-10-23WarningsExact identifier
spl set id: e3ac8a17-8483-4814-b36e-c1ad41e4b20c

Reported adverse events (FAERS/openFDA)#

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