FDA.reportPublic FDA data

OCTISALATE,OCTOCRYLENE,OCTINOXATE,ZINC OXIDE,TITANIUM DIOXIDE,ENSULIZOLE

Manufacturer
PROKPIL SAS
Effective date
2021-03-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:38:41

Label at a glance#

ProductOCTISALATE,OCTOCRYLENE,OCTINOXATE,ZINC OXIDE,TITANIUM DIOXIDE,ENSULIZOLE
Active ingredientTITANIUM DIOXIDE, OCTOCRYLENE, ENSULIZOLE, OCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure12 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (seek 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 water resistant sun protector if swimming or sweating. Reapply at least every two hours. Children under six months: ask a doctor Sun protection measures: Overexposure to the sun is dangerous. Increases the risk of causing skin cancer and premature aging. To reduce the risk, regularly use sunscreen with broad spectrum SPF 15 or higher, combined with other sun prote...

Storage and handling

Protect from excessive heat and direct sunlight. Formulated without: parabens, silicones, mineral oils, synthetic dyes.

Label contents#

Full prescribing information#

LOSANIKA ALOE & CALENDULA ANTIOXIDANT SUNSCREEN BROAD SPECTRUM SPF 30 - ENSULIZOLE 2.0 %, TITANIUM DIOXIDE 2.4 %, OCTOCRYLENE 3.0 %, ZINC OXIDE 3.5 %, OCTISALATE 4.5 %, OCTINOXATE 6.5 %

OTC - PURPOSE SECTION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with

regulations and policies. FDA has not evaluated weather this product complies.

PURPOSE:

OTC - PURPOSE SECTION

SUNSCREEN

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

ENSULIZOLE 2.0 %

TITANIUM DIOXIDE 2.4 %

OCTOCRYLENE 3.0 %

ZINC OXIDE 3.5 %

OCTISALATE 4.5 %

OCTINOXATE 6.5 %

USES:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (seek Directions), decreases

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

WARNING:

WARNINGS SECTION

For external use only.

Do not use 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 - ASK DOCTOR SECTION

If rash or irritation develops or lasts.

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:

OTC - PURPOSE SECTION

Apply liberally 15 minutes before sun exposure

Use water resistant sun protector if swimming or sweating.
Reapply at least every two hours.
Children under six months: ask a doctor

Sun protection measures:

Overexposure to the sun is dangerous. Increases the risk of causing skin cancer and premature aging.

To reduce the risk, regularly use sunscreen with broad spectrum SPF 15 or higher, combined with other sun protection measures. Limit exposure time especially between 10 am - 2 pm. Wear long sleeves, hat and glasses.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe vera (Aloe) Leaf juice, Calendula officinalis (calendula) flower extract, Aluminum Starch Octenylsuccinate,C12-15 Alkyl Benzoate, Propylheptyl Caprylate, Dicaprylyl Carbonate (and) Stearalkonium Hectorite (and) Propylene Carbonate, Cetearyl Alcohol, Hydrogenated Castor Oil, Polyglyceryl-2 Dipolyhydroxystearate, Coffea arabica (Coffee) seed oil, Sodium Stearoyl Glutamate, Tocopheryl Acetate(E), Niacinamide (B3), Panthenol, Glycerin, Xanthan Gum, Fragrance, Phenoxyethanol (And) Decylene Glycol (And) Caprylyl Glycol, Bixa Orellana Seed Extract (Annato), Cymbopogon citratus (lemongrass) oil, Zingiber officinale (ginger) root oil, Citrus sinensis (sweet orange) peel oil, Lippia alba (bushy matgrass) leaf/stem oil.

OTHER INFORMATION:

STORAGE AND HANDLING SECTION

Protect from excessive heat and direct sunlight.

Formulated without: parabens, silicones, mineral oils, synthetic dyes.

CONTENT OF LABELING:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CONTENT OF LABELINGCONTENT OF LABELING

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71801-542-012022-07-29C16284748780-1ab0e2407-2f7e-f274-e053-dbdaa90a6471ALOE & CALENDUAL ANTIOXIDENT SUNSCREEN BROAD SPECTRUM SPF30
71801-542-012021-03-02C16284748780-1ab0e2407-2f7e-f274-e053-dbdaa90a6471ALOE & CALENDUAL ANTIOXIDENT SUNSCREEN BROAD SPECTRUM SPF30
71801-542-012020-09-27C16284748780-1ab0e2407-2f7e-f274-e053-dbdaa90a6471ALOE & CALENDUAL ANTIOXIDENT SUNSCREEN BROAD SPECTRUM SPF30
71801-542-012020-09-25C16284748780-1ab0e2407-2f7e-f274-e053-dbdaa90a6471ALOE & CALENDUAL ANTIOXIDENT SUNSCREEN BROAD SPECTRUM SPF30
71801-542-012020-07-22C16284748780-1ab0e2407-2f7e-f274-e053-dbdaa90a6471ALOE & CALENDUAL ANTIOXIDENT SUNSCREEN BROAD SPECTRUM SPF30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71801-542-01OCTISALATE,OCTOCRYLENE,OCTINOXATE,ZINC OXIDE,TITANIUM DIOXIDE,ENSULIZOLE30 g in 1 BOXCREAM304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71801-542OCTISALATE,OCTOCRYLENE,OCTINOXATE,ZINC OXIDE,TITANIUM DIOXIDE,ENSULIZOLE CREAM [PROKPIL SAS]4Legacy NDC, 1 package rows20210303_6eafbc1c-44d8-5837-e053-2a91aa0ad979.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71801-54271801-542-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PROPYLHEPTYL CAPRYLATE991Z19V2ODIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
BIXA ORELLANA SEEDO87354RZ5AIACT
NIACINAMIDE25X51I8RD4IACT
WEST INDIAN LEMONGRASS OIL5BIA40E9EDIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DECYLENE GLYCOLS57M60MI88IACT
GINGER OILSAS9Z1SVUKIACT
OCTOCRYLENE5A68WGF6WMACTIB
ENSULIZOLE9YQ9DI1W42ACTIB
XANTHAN GUMTTV12P4NEEIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
ARABICA COFFEE OILIK55HKE887IACT
PANTHENOLWV9CM0O67ZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
LIPPIA ALBA WHOLE76HT054LK1IACT
ORANGE OILAKN3KSD11BIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
PROPYLENE CARBONATE8D08K3S51EIACT

Source Document#

Source XML

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
bc8d9915-7e81-37e9-e053-2995a90a1cbf6eafbc1c-44d8-5837-e053-2a91aa0ad9792021-03-02WarningsExact identifier
spl id: bc8d9915-7e81-37e9-e053-2995a90a1cbf
spl set id: 6eafbc1c-44d8-5837-e053-2a91aa0ad979

Reported adverse events (FAERS/openFDA)#

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