Indications and uses
Helps prevent sunburn
Octinoxate, Oxybenzone, and Titanium Dioxide
- Manufacturer
- Ventura Corporation LTD | Bel Star S.A. (Colombia)
- Effective date
- 2014-03-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:37:06
Label at a glance#
ProductESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 1) - ROSE
Active ingredientOctinoxate, Oxybenzone, Titanium Dioxide
Label structure21 sections
Dosage and administration
Apply liberally and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
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
Active Ingredients
OCTINOXATE 7.0 %,OXYBENZONE 2.0%, TITANIUM DIOXIDE 2.0%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
Warnings
SPL UNCLASSIFIED SECTION
- Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
- For external use only.
OTC - DO NOT USE SECTION
- Do not use on damage or broken skin.
OTC - WHEN USING SECTION
- When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE 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
- Apply liberally and evenly 15 minutes before sun exposure.
- Children under 6 months of age: Ask a doctor.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
Other information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE, C12-15 ALKYL BENZOATE,POLYMETHYL METHACRYLATE, ZEA MAYS STARCH (ZEA MAYS (CORN) STARCH), SILICA, MICA, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL PALMITATE, OZOKERITE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA) WAX), BENZOPHENONE-3, TITANIUM DIOXIDE, PHENOXYETHANOL, OCTYLDODECANOL, TRIMETHYLSILOXYSILICATE, DIMETHICONE, METHYLPARABEN, TOCOPHERYL ACETATE, MICROCRISTALLINA CERA (MICROCRYSTALLINE WAX), PROPYLPARABEN, PETROLATUM, PHOSPHOLIPIDS, BHT, C9-13 FLUOROALCOHOL, BUTYLPARABEN, ETHYLPARABEN, PHOSPHORIC ACID, CHOLESTEROL, ISOBUTYLPARABEN, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), CERA ALBA (BEESWAX), CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, GLYCOSPHINGOLIPIDS. May contain: CI 77491 (IRON OXIDES), CI 77492 (IRON OXIDES), CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CHITOSAN.
SPL UNCLASSIFIED SECTION
P.R.: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 1) - ROSE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 2) - ROSE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 3) - ROSE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 4) - ROSE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 5) - ROSE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box (ROSE 6) - ROSE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 1) - BEIGE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 2) - BEIGE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 3) - BEIGE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 4) - BEIGE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 5) - BEIGE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 6) - BEIGE
ésika
3-in-1 Pro Make Up
Foundation SPF 20
Base de Maquillaje para Rostro
3-en-1 Pro FPS 20
6 g e (.21 oz.)
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CETEARYL GLUCOSIDE | INACTIVE INGREDIENT | 09FUA47KNA | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CHOLESTEROL | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 1 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| ISOBUTYLPARABEN | INACTIVE INGREDIENT | 0QQJ25X58G | 1 | |
| ISOSTEARYL NEOPENTANOATE | INACTIVE INGREDIENT | 411THY156Q | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | 1 | |
| POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE | INACTIVE INGREDIENT | 9229XJ4V12 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 1) - ROSE
- Octinoxate, Oxybenzone, and Titanium Dioxide
- Octinoxate
- Oxybenzone
- Titanium Dioxide
- ISOSTEARYL NEOPENTANOATE
- ALKYL (C12-15) BENZOATE
- STARCH, CORN
- SILICON DIOXIDE
- MICA
- ETHYLHEXYL PALMITATE
- CARNAUBA WAX
- PHENOXYETHANOL
- OCTYLDODECANOL
- DIMETHICONE
- METHYLPARABEN
- .ALPHA.-TOCOPHEROL ACETATE
- MICROCRYSTALLINE WAX
- PROPYLPARABEN
- PETROLATUM
- BUTYLATED HYDROXYTOLUENE
- BUTYLPARABEN
- ETHYLPARABEN
- PHOSPHORIC ACID
- CHOLESTEROL
- ISOBUTYLPARABEN
- POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
- CANDELILLA WAX
- YELLOW WAX
- CETEARYL GLUCOSIDE
- CETOSTEARYL ALCOHOL
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- FERROSOFERRIC OXIDE
- ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 2) - ROSE
- ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 3) - ROSE
- ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 4) - ROSE
- ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 5) - ROSE
- ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 6) - ROSE
- ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 1) - BEIGE
NDC Codes#
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | ADJ PH | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CREAM / VAGINAL | 23 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | FILM, EXTENDED RELEASE / TRANSDERMAL | 253.4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / TOPICAL | 180 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | SPRAY / TOPICAL | 1 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| CHOLESTEROL | CHOLESTEROL | 97C5T2UQ7J | CREAM / TOPICAL | 1 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | CREAM / TOPICAL | 160 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, FILM COATED / ORAL | 0.8 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | TABLET, ORALLY DISINTEGRATING / ORAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRALESIONAL | 0.02 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION, CONCENTRATE / ORAL | 0.1 mg/1ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CONCENTRATE / ORAL | 2.5 mg/5ml | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | SUSPENSION / ORAL | 6 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SYRUP / ORAL | 28.4 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | CREAM / VAGINAL | 0.56 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SUPPOSITORY / VAGINAL | 27 mg | ||
| CHOLESTEROL | CHOLESTEROL | 97C5T2UQ7J | INJECTABLE, LIPOSOMAL / INFILTRATION | 0.47 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, CHEWABLE / ORAL | 0.14 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SHAMPOO / TOPICAL | 0.1 %w/w | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | OINTMENT / TOPICAL | 3575 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, DELAYED RELEASE / ORAL | 1 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | ADJ PH | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, COATED / ORAL | 0.8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAMUSCULAR | 5 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 32c28f6b-8a8b-460c-e063-6394a90aabb9 | bd3d0467-41aa-4a2a-a371-646fc5880f97 | 2025-04-14 | Warnings | bd3d0467-41aa-4a2a-a371-646fc5880f97 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.