FDA.reportPublic FDA data

OCTINOXATE, TITANIUM DIOXIDE

Manufacturer
Guerlain
Effective date
2015-06-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:31:22

Label at a glance#

ProductSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

For sunscreen use: Apply liberally 15 minutes before sun exposure. reapply at least every two 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 value of 15 or higher and other sun protection measures including: Limit time...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.49%
Titanium Dioxide 3.84%

Purpose

OTC - PURPOSE SECTION

sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

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

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 a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure.
  • reapply at least every two 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 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA (WATER) - GLYCERIN - BUTYLENE GLYCOL - SQUALANE - PROPANEDIOL - PHENYL TRIMETHICONE - ETHYLHEXYL ISONONANOATE - SILICA - GLYCERYL STEARATE SE - PEG-60 HYDROGENATED CASTOR OIL - PENTYLENE GLYCOL - PHENOXYETHANOL - AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER - STEARYL ALCOHOL - DICAPRYLYL ETHER - STEARIC ACID - PARFUM (FRAGRANCE) - HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER - PHOSPHOLIPIDS - SODIUM HYALURONATE - TOCOPHERYL ACETATE - HYDROLYZED MILLET - ALUMINA - XYLOSE - SODIUM CITRATE - POLYGLYCERYL-10 STEARATE - DISODIUM EDTA - RUSCUS ACULEATUS ROOT EXTRACT - POLYSORBATE 50 - VIOLA TRICOLOR EXTRACT - CITRONELLOL - CITRIC ACID - BHT - GERANIOL - BUTYLPHENYL METHYLPROPIONAL - HEXYL CINNAMAL - BENZYL SALICYLATE - LINALOOL - ETHYLHEXYLGLYCERIN - TOCOPHEROL - [MAY CONTAIN: CI 77891 (TITANIUM DIOXIDE) - CI 77492, CI 77491, CI 77499 (IRON OXIDES)] (08038)

Other information

SPL UNCLASSIFIED SECTION

  • Protects this product from excessive heat and direct sun.

Question or comments?

OTC - QUESTIONS SECTION

In USA: 19 East, 57th Street, New York, NY 10022

GUERLAIN SUPER AQUA-SERUM BB HYDRA + BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Label MediumTube Label MediumOuter Label MEDIUMOuter Label MEDIUM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD514
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP4
OCTINOXATEACTIVE MOIETY4Y5P7MUD514
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP4
.ALPHA.-HEXYLCINNAMALDEHYDEINACTIVE INGREDIENT7X6O37OK2I4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L04
.BETA.-CITRONELLOL, (R)-INACTIVE INGREDIENTP01OUT964K4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69334
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZG4
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TU4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K4
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA4
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV694
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP4
DICAPRYLYL ETHERINACTIVE INGREDIENT77JZM5516Z4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K4
ETHYLHEXYL ISONONANOATEINACTIVE INGREDIENTI6KB4GE3K44
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6754
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3574
GERANIOLINACTIVE INGREDIENTL837108USY4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785I4
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH4
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E4
PEG-60 HYDROGENATED CASTOR OILINACTIVE INGREDIENT02NG325BQG4
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T4
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R4
POLYGLYCERYL-10 STEARATEINACTIVE INGREDIENT90TF85HH914
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T4
RUSCUS ACULEATUS ROOTINACTIVE INGREDIENTZW12V95I1Q4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU44
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR4
SQUALANEINACTIVE INGREDIENTGW89575KF94
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y4
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P84
VIOLA TRICOLORINACTIVE INGREDIENT9Q24RAI43V4
WATERINACTIVE INGREDIENT059QF0KO0R4
XYLOSEINACTIVE INGREDIENTA1TA934AKO4

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49817-007949817-0079-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SQUALANEGW89575KF9IACT
PROPANEDIOL5965N8W85TIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
STEARYL ALCOHOL2KR89I4H1YIACT
DICAPRYLYL ETHER77JZM5516ZIACT
STEARIC ACID4ELV7Z65APIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALUMINUM OXIDELMI26O6933IACT
XYLOSEA1TA934AKOIACT
SODIUM CITRATE1Q73Q2JULRIACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
EDETATE DISODIUM7FLD91C86KIACT
RUSCUS ACULEATUS ROOTZW12V95I1QIACT
VIOLA TRICOLOR9Q24RAI43VIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
GERANIOLL837108USYIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
LINALOOL, (+/-)-D81QY6I88EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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 8 · 443 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YTABLET, EXTENDED RELEASE / ORAL244 mgExact identifier — unii candidate
12 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KFILM, SOLUBLE / ORAL0.06 mgExact identifier — unii candidate
32 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAVITREAL23 mgExact identifier — unii candidate
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / BUCCAL0.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / ORAL14 mgExact identifier — unii candidate
32 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL STEARATE SEGLYCERYL STEARATE SEFCZ5MH785ILOTION / TOPICAL46 mgExact identifier — unii candidate
2 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 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
9948546f-e54d-7f2c-e053-2995a90a70215d68c803-8624-41ff-9294-706d764ee7a42019-12-09WarningsExact identifier
spl set id: 5d68c803-8624-41ff-9294-706d764ee7a4

Reported adverse events (FAERS/openFDA)#

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