FDA.reportPublic FDA data

ESIKA

Manufacturer
Ventura Corporation, Ltd. | Bel Star S.A. (Colombia)
Effective date
2012-01-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:49:46

Label at a glance#

ProductESIKA PERFECT SUN
Active ingredientAvobenzone, Octisalate, Octocrylene, Oxybenzone
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 and evenly 15 minutes before sun exposure. Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
AVOBENZONE (3.0%)Sunscreen
OCTISALATE (5.0%)Sunscreen
OCTOCRYLENE (10.0%)Sunscreen
OXYBENZONE:6.0%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.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

OTC - ASK DOCTOR SECTION
  • Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

ALCOHOL DENAT., CYCLOPENTASILOXANE, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, C12-15 ALKYL BENZOATE, DIMETHICONE, FRAGRANCE, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE.

SPL UNCLASSIFIED SECTION

P.R.: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 150 ml Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF
30
BROAD
SPECTRUM

Perfect
sun

sunscreen body spray SPF 30
WATER RESISTANT
(40 MINUTES)

ēsika

150 ml e (5 fl.oz.)

PRINCIPAL DISPLAY PANEL - 150 ml Bottle
PRINCIPAL DISPLAY PANEL - 150 ml Bottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13537-153-012025-04-30C16284748780-197449f38-cc83-f6ea-e053-dbdaa90aa703ēsika Perfect sun
13537-153-012019-11-13C16284748780-197449f38-cc83-f6ea-e053-dbdaa90aa703ēsika Perfect sun

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
alkyl (c12-15) benzoateINACTIVE INGREDIENTA9EJ3J61HQ1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
alpha-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L01
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13537-15313537-153-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Oxybenzone95OOS7VE0YACTIB
cyclomethicone 50THT5PCI0RIACT
alkyl (c12-15) benzoateA9EJ3J61HQIACT
dimethicone92RU3N3Y1OIACT
alpha-tocopherol acetate9E8X80D2L0IACT
aloe vera leafZY81Z83H0XIACT

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 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
alpha-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
alpha-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
alpha-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 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
3400effd-8796-ccaf-e063-6294a90ae7654f3a8ee4-f059-40a3-9ed0-e52b15bc0aab2025-04-30WarningsExact identifier
spl set id: 4f3a8ee4-f059-40a3-9ed0-e52b15bc0aab

Reported adverse events (FAERS/openFDA)#

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