Octinoxate

Manufacturer
Hayden Caleel LLC
Effective date
2013-08-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:42:34

Label at a glance#

ProductOctinoxate
Active ingredientOctinoxate
Label structure10 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 use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months of age: Ask a doctor 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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5%

Titanium Dioxide 10%

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of the eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor

Sun Protection Measures

SPL UNCLASSIFIED SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water/Eau), Ethylhexyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Trimellitate, Silica, Cyclopentasiloxane, Caprylic/Capric Triglyceride, HDI/Trimethylol Hexyllactone Crosspolymer, Butylene Glycol, Glycerin, Polyglyceryl-3 Diisostearate, Cyclohexasiloxane, Octyldodecanol, Octyldecyl Xyloside, PEG-30 Dipolyhydroxystearate, Silica Dimethyl Silylate, Phenoxyethanol, Hydroxyethylacrylate/Sodium Acryloydimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Caprylyl Glycol, Ethylhexyl Glycerin, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Polymethylsilsesquioxane, Dimethicone, Retinyl Palmitate (Vitamin A), Triethoxycaprylylsilane, Camellia Oleifera (Green Tea) Leaf Extract, Diamond Powder, (+/-):Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Questions or comments?

OTC - QUESTIONS SECTION

Call: 1.800.232.0398 M-F 9am-6pm MST

Principal Display Panel - 30 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LUXE

LIQUID FOUNDATION

BROAD SPECTRUM SPF 18

ANTI-AGING

DIAMOND POWDER

TECHNOLOGY

glo·minerals

30 mL / 1 fl. oz.

Principal Display Panel - 30 mL Carton Label
Principal Display Panel - 30 mL Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60541-8407-42020-01-31C16284748780-19d75b9d0-715f-f424-e053-dadaa90a57ce3a4e17fb-22c8-4c79-a140-17000ff13802

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60541-8407-4Octinoxate30 mL in 1 BOTTLELOTION302
60541-8407-4Octinoxate1 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60541-8407OCTINOXATE LOTION [HAYDEN CALEEL LLC]2Legacy NDC, 2 package rows20150522_3a4e17fb-22c8-4c79-a140-17000ff13802.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD512
OctinoxateACTIVE MOIETY4Y5P7MUD512
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L02
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA2
Camellia Oleifera LeafINACTIVE INGREDIENT5077EL0C602
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U2
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R2
Cyclomethicone 6INACTIVE INGREDIENTXHK3U310BA2
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O2
Ethylhexyl PalmitateINACTIVE INGREDIENT28659933092
EthylhexylglycerinINACTIVE INGREDIENT147D247K3P2
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G6752
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
Hexylene GlycolINACTIVE INGREDIENTKEH0A3F75J2
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.S At 1%)INACTIVE INGREDIENT86FQE96TZ42
IsohexadecaneINACTIVE INGREDIENT918X1OUF1E2
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7U2
Neopentyl Glycol Dicaprylate/DicaprateINACTIVE INGREDIENTVLW429K27K2
OctyldodecanolINACTIVE INGREDIENT461N1O614Y2
Peg-30 DipolyhydroxystearateINACTIVE INGREDIENT9713Q0S7FO2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T2
Polyglyceryl-3 DiisostearateINACTIVE INGREDIENT46P231IQV82
Polymethylsilsesquioxane (4.5 Microns)INACTIVE INGREDIENT59Z907ZB692
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4M2
Silica Dimethyl SilylateINACTIVE INGREDIENTEU2PSP0G0W2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU42
Tetrahexyldecyl AscorbateINACTIVE INGREDIENT9LBV3F07AZ2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP2
Tridecyl TrimellitateINACTIVE INGREDIENTFY36J270ES2
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08E2
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVC2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60541-840760541-8407-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

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 · 250 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
Silica Dimethyl SilylateSILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, CHEWABLE / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MEMULSION / ORAL20 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
Silica Dimethyl SilylateSILICA DIMETHYL SILYLATEEU2PSP0G0WSUSPENSION / ORAL120 mgExact identifier — unii candidate
7 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / RECTAL0.05 mg/mgExact identifier — unii candidate
13 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii candidate
13 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
OctyldodecanolOCTYLDODECANOL461N1O614YGEL / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
OctyldodecanolOCTYLDODECANOL461N1O614YCREAM / VAGINAL13.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
Silica Dimethyl SilylateSILICA DIMETHYL SILYLATEEU2PSP0G0WCAPSULE / ORAL0.5 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET / BUCCAL0.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 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
332c5fb6-263c-4b12-b37b-59a80c19c71e3a4e17fb-22c8-4c79-a140-17000ff138022013-08-27WarningsExact identifier
spl id: 332c5fb6-263c-4b12-b37b-59a80c19c71e
spl set id: 3a4e17fb-22c8-4c79-a140-17000ff13802

Reported adverse events (FAERS/openFDA)#

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