Avobenzone, Homosalate, Octisalate and Octocrylene

Manufacturer
Emilia Personal Care Inc.
Effective date
2014-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:03

Label at a glance#

ProductDesert Fusion Nutritious Olive Leaf Daily Defense Broad Spectrum SPF 15 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 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 • Reapply at least every 2 hours • Use water resistant sunscreen if swimming or sweating • Children under 6 months of age: 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 m...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone, 3.0%

Homosalate, 5.0%

Octisalate, 5.0%

Octocrylene, 4.0%

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 risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

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

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

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use water resistant sunscreen if swimming or sweating
  • Children under 6 months of age: 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. – 2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cyclopentasiloxane, C12-15 alkyl benzoate, glyceryl stearate, PEG-100 stearate, steareth-2, polyacrylamide, C13-14 isoparaffin, laureth-7, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, cetearyl alcohol, cetearyl glucoside, steareth-21, glycerin, cetearyl alcohol, phenoxyethanol, triethylene glycol, polymethyl methacrylate, silica, lecithin, soy isoflavones, polysorbate 80, sodium lactate, porphyra umbilicalis extract, panthenol (pro-vitamin B5), opuntia streptacantha stem extract, butyrospermum parkii (shea butter), fragrance, olea europaea (olive) leaf extract, disodium EDTA, olea europaea (olive) fruit oil, simmondsia chinensis (jojoba) seed oil, lavendula angustifolia (lavender) oil, aloe barbadensis leaf juice, benzalkonium chloride, BHT, maris sal (dead sea mineral water), triethanolamine.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

nutritious
olive leaf daily defense
broad spectrum SPF 15
sunscreen

DESERT
FUSION™
sea | earth | botanicals

featuring
Aquaguard
Skin Marvel™

quench+protect
paraben-free

1.7 FL OZ (50 mL)

nutritious olive leaf daily defense
broad spectrum SPF 15 sunscreen

Olive leaf has been used for centuries as a medicinal plant due to its high concentration of antioxidants and phytonutrients. Desert Fusion’s Nutritious Olive Leaf Daily Defense Broad Spectrum SPF 15 Sunscreen harnesses the power of the olive to neutralize damaging free radicals and protect skin from irritants. The natural botanicals helps hydrate and nourish the skin throughout the day for healthier, radiant looking skin.

Directions: Apply every morning to clean skin for a healthier looking complexion and to fight the signs of aging.

Visit us at www.desertfusionskincare.com

Made and Exclusively Crafted in Israel

Distributed by:
Emilia Personal Care
5890 Sawmill Road
Suite 230
Dublin, OH 43017

WD629

Carton Label
Carton Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42421-692-122020-01-31C16284748780-19d75b9d0-0ea4-f424-e053-dadaa90a57ceDesert Fusion Nutritious Olive Leaf Daily Defense Broad Spectrum SPF 15 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42421-692-12Desert Fusion Nutritious Olive Leaf Daily Defense Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM11
42421-692-12Desert Fusion Nutritious Olive Leaf Daily Defense Broad Spectrum SPF 15 Sunscreen50 g in 1 JARCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42421-692DESERT FUSION NUTRITIOUS OLIVE LEAF DAILY DEFENSE BROAD SPECTRUM SPF 15 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) CREAM [EMILIA PERSONAL CARE INC.]1Legacy NDC, 2 package rows20141209_d1d1084d-1591-4273-82a1-6b6c23b62a9f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ARACHIDYL ALCOHOLINACTIVE INGREDIENT1QR1QRA9BU1
ARACHIDYL GLUCOSIDEINACTIVE INGREDIENT6JVW35JOOJ1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE701
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNA1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
LAURETH-7INACTIVE INGREDIENTZ95S6G82011
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH471
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
OPUNTIA STREPTACANTHA STEMINACTIVE INGREDIENT3TF9Z1U73O1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLY(METHYL METHACRYLATE; 450000 MW)INACTIVE INGREDIENTZ47NNT4J111
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PORPHYRA UMBILICALISINACTIVE INGREDIENT14AN0J70WO1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QT1
SOY ISOFLAVONESINACTIVE INGREDIENT71B37NR06D1
STEARETH-2INACTIVE INGREDIENTV56DFE46J51
STEARETH-21INACTIVE INGREDIENT53J3F32P581
TRIETHYLENE GLYCOLINACTIVE INGREDIENT3P5SU533601
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42421-69242421-692-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 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 8 · 422 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, LIQUID FILLED / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii candidate
32 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / VAGINAL0.4 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM LACTATESODIUM LACTATETU7HW0W0QTINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS18.7 mgExact identifier — unii candidate
7 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM LACTATESODIUM LACTATETU7HW0W0QTSOLUTION / TOPICAL0.93 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / TOPICAL0.98 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / VAGINAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact 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
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
STEARETH-2STEARETH-2V56DFE46J5OINTMENT / TOPICAL714 mgExact identifier — unii candidate
4 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, FOR SUSPENSION / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 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
d1d1084d-1591-4273-82a1-6b6c23b62a9fd1d1084d-1591-4273-82a1-6b6c23b62a9f2014-12-08WarningsExact identifier
spl id: d1d1084d-1591-4273-82a1-6b6c23b62a9f
spl set id: d1d1084d-1591-4273-82a1-6b6c23b62a9f

Reported adverse events (FAERS/openFDA)#

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