Lorac Foundation Medium

Manufacturer
Lorac Cosmetics, Inc.
Effective date
2022-06-06
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
legacy-cache
Hydrated at
2026-08-01 22:00:01

Label at a glance#

ProductLorac Foundation Medium SPF20
Active ingredientOCTINOXATE, OCTISALATE, AVOBENZONE
Label structure8 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures ( See Directions ), decreases the rist of skin cancer and early skin-aging cause by the sun.

Dosage and administration

Apply 15 minutes prior to sun exposure and reapply as needed Spending time in the sun increases your risk of skin cancer and early skin aging To decrease this risk, regularly use a sunscreen with Broad Spectrum value at 15 or higher and other sun protection measures including Limit time in the sun, expecially from 10 a.m. to 2 p.m. Wear long-sleeved shirts, hats, pants and sunglasses Children under 6 months of age...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Octinoxate 7.5%

Ocitsalate 5.0%

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 rist of skin cancer and early skin-aging cause by the sun.

Warnings

WARNINGS AND PRECAUTIONS SECTION

For exteral use Only

  • Keep away  from the eye area
  • Stop use if irritation occurs
  • If irritation persists consult a health practitioner

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

Directions

DOSAGE & ADMINISTRATION SECTION

Apply 15 minutes prior to sun exposure and reapply as needed

  • Spending time in the sun increases your risk of skin cancer and early skin aging
  • To decrease this risk, regularly use a sunscreen with Broad Spectrum value at 15 or higher and other sun protection measures including
  • Limit time in the sun, expecially from 10 a.m. to 2 p.m.
  • Wear long-sleeved shirts, hats, pants and sunglasses
  • Children under 6 months of age: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, CYCLOPENTASILOXANE, POLYMETHYLSILSESUIOXANE, ETHYLHEXYL PALMITATE, GLYCERIN, NEOPENTYL GLYCOL DIHEPTANOATE, TRIMETHYLSILOXYSILICATE,  HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, QUATERNIUM-90 BENTONITE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, POTASSIUM SORBATE, PHENYL TRIMETHICONE, TOCOPHERYL ACETATE, POLYGLYCERYL-3 BEESWAX,  MICROCRYSTALINE WAX, PROPYLENE CARBONATE, RETINYL PALMITATE, POLYHYDROXYSTEARIC ACID, LECITHIN, ISOPROPYL MYRISTATE, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, PHENOXYETHANOL, CAPRYLYL GLYCOL, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT, MAY CONTAIN : TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI77492, CI 77491, CI 77499), MICA (CI 77019).

Questions or Comments

OTC - QUESTIONS SECTION

Call Customer Care 1-800-845-0705

Mon-Fri between 8 am - 4pm PST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LoracSPF20CtnLoracSPF20Ctn

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX6
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD516
OCTISALATEACTIVE INGREDIENT4X49Y0596W6
AVOBENZONEACTIVE MOIETYG63QQF2NOX6
OCTINOXATEACTIVE MOIETY4Y5P7MUD516
OCTISALATEACTIVE MOIETY4X49Y0596W6
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW86
BENTOQUATAMINACTIVE INGREDIENT7F465U79Q16
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U6
CARICA PAPAYA WHOLEINACTIVE INGREDIENTS0U63B0Q516
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0X6
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ6
CITRUS MEDICA FRUITINACTIVE INGREDIENTZE5Q6PN9ON6
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R6
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGV6
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933096
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
HEXAMETHYLENE DIISOCYANATEINACTIVE INGREDIENT0I70A3I1UF6
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS6
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00626
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB6
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY6
NEOPENTYL GLYCOL DIHEPTANOATEINACTIVE INGREDIENT5LKW3C543X6
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH476
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T6
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R6
POLYGLYCERYL-3 DIISOSTEARATEINACTIVE INGREDIENT46P231IQV86
POLYGLYCERYL-3 RICINOLEATEINACTIVE INGREDIENTMZQ63P0N0W6
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F6
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)INACTIVE INGREDIENT59Z907ZB696
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ46
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51E6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X6
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E6
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)INACTIVE INGREDIENT5041RX63GN6
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC6
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52773-23852773-238-01, 52773-238-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 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 6 · 311 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / ORALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ENDOTRACHEAL46.76 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INFILTRATION648 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET, FILM COATED / ORAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYSTEM / TOPICAL3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRASYNOVIAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / INTRAMUSCULAR9 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER / TOPICALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY, METERED / NASAL36 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / NASAL7.4 mg/1mlExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR226 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / OPHTHALMIC0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XELIXIR / ORAL1 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / OPHTHALMIC13 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PARENTERAL584 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / AURICULAR (OTIC)18 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAVITARY0.82 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOIL / AURICULAR (OTIC)36 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOINTMENT / TOPICAL35 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE CARBONATEPROPYLENE CARBONATE8D08K3S51EOINTMENT / TOPICAL3000 mgExact identifier — unii candidate
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVINJECTION, EMULSION / INTRAVENOUS12852 mgExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / EPIDURAL3535 mgExact identifier — unii candidate
134 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
45856865-b1c0-4a9d-9f4a-7ea4d397db6d3ee84a67-1cd2-4bb0-91a8-adf8c91ea3bb2022-06-06WarningsExact identifier
spl id: 45856865-b1c0-4a9d-9f4a-7ea4d397db6d
spl set id: 3ee84a67-1cd2-4bb0-91a8-adf8c91ea3bb

Reported adverse events (FAERS/openFDA)#

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