FDA.reportPublic FDA data

Lipidol

Manufacturer
UNION-SWISS (PTY) LTD | COLUMBIA PHARMACEUTICALS (PTY) LTD
Effective date
2015-11-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:10

Label at a glance#

ProductLipidol
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                              Purpose

Avobenzone 3%

Homosalate 6%

Octisalate 5%

Octocrylene 6.5% ............................... Sunscreen

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Lipidol 

Sunscreen Broad Spectrum SPF 20

4.2 fl. oz.

DOSAGE & ADMINISTRATION SECTION

Directions
apply liberally 15 minutes before sun exposure
reapply:

  • at least every 2 hours
  • immediately after towel drying

use a water resistant sunscreen if swimming or sweating
children under 6 months: Ask a doctor
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.-2p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

WARNINGS SECTION

Warnings

For external use only

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

mineral oil (paraffinum liquidum), isopropyl palmitate, cetearyl ethylhexanoate, C12-15 alkyl benzoate, oryxanol, bisabolol, tocopheryl acetate, pyridoxine dipalmitate, octyldodecyl PCA, phytosterols, carthamus tinctorius (safflower) seed oil, borago officinalis (borage) seed oil, linoleic acid, linolenic acid, butylene glycol, BHT, cupressus simpervirens oil, ocimum basilicum (basil) oil, melia azadirachta leaf extract, melia azadirachta flower extract, aspartic acid, arginine, glycine, glutamic acid, histidine, coccinia indica fruit extract, solanum melongena (eggplant) fruit extract, aloe barbadensis flower extract, lawsonia inermis (henna) flower/fruit/leaf extract, ocimum sanctum leaf extract, ocimum basilicum (basil) flower/leaf extract, curcuma longa (turmeric) root extract, corallina officinalis extract, simmondsia chinensis (jojoba) seed oil, farnesol, limonene

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69359-000-002020-01-31C16284748780-19d75b9cf-fbe7-f424-e053-dadaa90a57cea500a64b-319f-476f-ac38-1648b587acf5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69359-000-00Lipidol125 mL in 1 BOTTLEOIL1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69359-000LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]2Legacy NDC, 1 package rows20151124_a500a64b-319f-476f-ac38-1648b587acf5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
HOMOSALATEACTIVE INGREDIENTV06SV4M95S2
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
HOMOSALATEACTIVE MOIETYV06SV4M95S2
OCTISALATEACTIVE MOIETY4X49Y0596W2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
.BETA.-SITOSTEROLINACTIVE INGREDIENTS347WMO6M42
ALOE VERA FLOWERINACTIVE INGREDIENT575DY8C1ER2
ARGININEINACTIVE INGREDIENT94ZLA3W45F2
ASPARTIC ACIDINACTIVE INGREDIENT30KYC7MIAI2
AZADIRACHTA INDICA WHOLEINACTIVE INGREDIENTMRL4DVG1F62
BORAGO OFFICINALIS SEEDINACTIVE INGREDIENT2GXJ790US02
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ2
CERAMIDE 1INACTIVE INGREDIENT5THT33P7X72
CETEARYL ETHYLHEXANOATEINACTIVE INGREDIENT9M64UO4C252
COCCINIA GRANDIS FRUITINACTIVE INGREDIENTVLJ6WOT3K52
CORALLINA OFFICINALISINACTIVE INGREDIENT4004498D062
CUPRESSUS SEMPERVIRENS LEAF OILINACTIVE INGREDIENTM7QUY89S4O2
CURCUMA LONGA WHOLEINACTIVE INGREDIENTW5488JUO8U2
FARNESOLINACTIVE INGREDIENTEB41QIU6JL2
GAMMA ORYZANOLINACTIVE INGREDIENTSST9XCL51M2
GLUTAMIC ACIDINACTIVE INGREDIENT3KX376GY7L2
GLYCINEINACTIVE INGREDIENTTE7660XO1C2
HISTIDINEINACTIVE INGREDIENT4QD397987E2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M2
JOJOBA OILINACTIVE INGREDIENT724GKU717M2
LAWSONIA INERMIS WHOLEINACTIVE INGREDIENTW7M7338R562
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T2
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1W2
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJ2
LINOLENIC ACIDINACTIVE INGREDIENT0RBV727H712
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
OCIMUM BASILICUM WHOLEINACTIVE INGREDIENTP4815JL4O32
OCIMUM TENUIFLORUM WHOLEINACTIVE INGREDIENT7OS52KZ33J2
PYRIDOXINE DIPALMITATEINACTIVE INGREDIENTHB49XCT0292
SAFFLOWER SEEDINACTIVE INGREDIENT8FCL6A31TX2
SOLANUM MELONGENA WHOLEINACTIVE INGREDIENT5DS5EE0N932

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
69359-00069359-000-00

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
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
MINERAL OILT5L8T28FGPIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETEARYL ETHYLHEXANOATE9M64UO4C25IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
GAMMA ORYZANOLSST9XCL51MIACT
LEVOMENOL24WE03BX2TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PYRIDOXINE DIPALMITATEHB49XCT029IACT
CERAMIDE 15THT33P7X7IACT
.BETA.-SITOSTEROLS347WMO6M4IACT
SAFFLOWER SEED8FCL6A31TXIACT
BORAGO OFFICINALIS SEED2GXJ790US0IACT
LINOLEIC ACID9KJL21T0QJIACT
LINOLENIC ACID0RBV727H71IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CUPRESSUS SEMPERVIRENS LEAF OILM7QUY89S4OIACT
OCIMUM BASILICUM WHOLEP4815JL4O3IACT
AZADIRACHTA INDICA WHOLEMRL4DVG1F6IACT
ASPARTIC ACID30KYC7MIAIIACT
ARGININE94ZLA3W45FIACT
GLYCINETE7660XO1CIACT
GLUTAMIC ACID3KX376GY7LIACT
HISTIDINE4QD397987EIACT
COCCINIA GRANDIS FRUITVLJ6WOT3K5IACT
SOLANUM MELONGENA WHOLE5DS5EE0N93IACT
ALOE VERA FLOWER575DY8C1ERIACT
LAWSONIA INERMIS WHOLEW7M7338R56IACT
OCIMUM TENUIFLORUM WHOLE7OS52KZ33JIACT
CURCUMA LONGA WHOLEW5488JUO8UIACT
CORALLINA OFFICINALIS4004498D06IACT
JOJOBA OIL724GKU717MIACT
FARNESOLEB41QIU6JLIACT
LIMONENE, (+)-GFD7C86Q1WIACT

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 2 · 117 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HISTIDINEHISTIDINE4QD397987ESUSPENSION / ORAL5 mg/1mlExact identifier — unii candidate
7 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MGEL / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, SOLUTION / INTRAVENOUS0.42 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSHAMPOO / TOPICAL0.1 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FTABLET, FILM COATED / ORAL25 mgExact identifier — unii candidate
11 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CPASTE, DENTIFRICE / DENTAL0.34 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FTABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
11 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MOINTMENT / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTABLE, LIPOSOMAL / INTRAVENOUS0.38 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR6240 mgExact identifier — unii candidate
11 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.02 mgExact identifier — unii candidate
32 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
ASPARTIC ACIDASPARTIC ACID30KYC7MIAIINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, FOR SUSPENSION / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
LIMONENE, (+)-LIMONENE, (+)-GFD7C86Q1WTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CPOWDER, FOR SOLUTION / ORAL0.09 mgExact identifier — unii candidate
20 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL, SPRAY / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
20 equally ranked IID candidates
HISTIDINEHISTIDINE4QD397987EINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS0.16 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION / INTRAMUSCULAR68 mgExact identifier — unii candidate
20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
11 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION, CONCENTRATE / ORAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, EXTENDED RELEASE / ORAL0.03 mgExact identifier — unii candidate
32 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
HISTIDINEHISTIDINE4QD397987EINJECTION / INTRAVENOUS465 mgExact identifier — unii candidate
7 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.5 mgExact identifier — unii candidate
20 equally ranked IID candidates
LIMONENE, (+)-LIMONENE, (+)-GFD7C86Q1WGEL / TOPICAL10 mgExact identifier — unii candidate
3 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii candidate
8 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MFILM, EXTENDED RELEASE / TRANSDERMAL187.5 mgExact identifier — unii candidate
8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii candidate
32 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET, CHEWABLE / ORAL267 mgExact identifier — unii candidate
20 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
e7c5fce0-d31f-4114-b8ea-610bef25431aa500a64b-319f-476f-ac38-1648b587acf52015-11-24WarningsExact identifier
spl id: e7c5fce0-d31f-4114-b8ea-610bef25431a
spl set id: a500a64b-319f-476f-ac38-1648b587acf5

Reported adverse events (FAERS/openFDA)#

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