OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE

Manufacturer
PROKPIL SAS
Effective date
2021-02-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:38:40

Label at a glance#

ProductOCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE
Active ingredientOCTISALATE, OCTOCRYLENE, ENSULIZOLE, AVOBENZONE, OCTINOXATE, TITANIUM DIOXIDE
Label structure12 sections

Indications and uses

For all sunscreen drug products: “helps prevent sunburn

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure Reapply at least every two hours Use water resistant sun protector if swimming or sweating. 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 exposur...

Storage and handling

Protect from excessive heat and direct sunlight. Formulated with out: Parabens, silicones, mineral oils, paraffins and synthetic fragrances

Label contents#

Full prescribing information#

LOSANIKA COFFEE BB CREAM BROAD SPECTRUM SPF 30 - Avobenzone 2%,Octocrylene 2%,Octinoxate 6%,Ensulizole 2%,Octisalate 4.5%. Titanium Dioxide 2.4% CREAM

OTC - PURPOSE SECTION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

PURPOSE:

OTC - PURPOSE SECTION

Sunscreen

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 2%

OCTOCRYLENE 2%

OCTINOXATE 6%

ENSULIZOLE 2%

OCTISALATE 4.5%

TITANIUM DIOXIDE 2.4%

USES:

INDICATIONS & USAGE SECTION

For all sunscreen drug products:
“helps prevent sunburn

WARNING:

WARNINGS SECTION


For external use only

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 the product is swallowed get medical help or contact a poison control center right away.

Directions:

OTC - PURPOSE SECTION

Apply generously and evenly 15 minutes before sun exposure

Reapply at least every two hours
Use water resistant sun protector if swimming or sweating.
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.
Children under 6 months of age ask a doctor.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water/Aqua, Aloe Barbadensis Leaf Water, Coffea Arabica Seed Extract, Coffea Arabica Seed Oil, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, Butyl Methoxydibenzoylmethane, Phenylbenzimidazole Sulfonic Acid, Octocrylene, Propylheptyl Caprylate,Titanium Dioxide, Calendula officinalis flower extract, Cetearyl Alcohol, Dicaprylyl Carbonate(and)Stearalkonium Hectorite (and) Propylene Carbonate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Panthenol,Sodium Polyacrylate, Phenoxyethanol and Caprylyl Glycol, Xanthan Gum, Polyamide – 3, Cymbopongo citratus leaf oil , Lippia Alba Leaf/Stem Oil, Citrus nobilis (mandarin orange) peel oil, CI 77891 (Titanium dioxide), CI 77491 (Iron oxide red), CI 77492 (Iron oxide yellow), CI 77499 (Iron oxide Black).

Ohter Information:

STORAGE AND HANDLING SECTION

Protect from excessive heat and direct sunlight.

Formulated with out:

Parabens, silicones, mineral oils, paraffins and synthetic fragrances

CONTENT OF LABELING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CONTENT OF LABELINGCONTENT OF LABELING

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71801-541-01OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE30 g in 1 BOXCREAM305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71801-541OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE CREAM [PROKPIL SAS]5Legacy NDC, 1 package rows20210303_5c4230af-280e-2b73-e053-2991aa0aa4a9.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71801-54171801-541-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

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
ba61353d-f750-704e-e053-2995a90abbf25c4230af-280e-2b73-e053-2991aa0aa4a92021-02-02WarningsExact identifier
spl id: ba61353d-f750-704e-e053-2995a90abbf2
spl set id: 5c4230af-280e-2b73-e053-2991aa0aa4a9

Reported adverse events (FAERS/openFDA)#

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