Indications and uses
Helps prevent sunburn.
esika
- Manufacturer
- Ventura Corporation LTD. | Bel Star S.A. (Colombia) | Yobel Supply Chain Management S.A. (Peru)
- Effective date
- 2012-12-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:44:01
Label at a glance#
Productesika Maximum Color Lipstick SPF 18
Active ingredientOCTINOXATE, Oxybenzone
Label structure10 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 7.3 %, Oxybenzone 1.65%
Purpose
Sunscreen
Uses
- Helps prevent sunburn.
Warnings
- 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
diisopropyl dimer dilinoleate, ethylhexyl palmitate, ozokerite, copernicia cerifera (carnauba) wax, polyethylene, butyrospermum parkii (shea) butter, silica, octyldodecanol, water, phenoxyethanol, microcrystalline wax, petrolatum, phospholipids, methylparaben, fragrance, bht, cholesterol, butylparaben, ethylparaben, euphorbia cerifera (candelilla) wax, beeswax, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, propylparaben, glycosphingolipids, maltodextrin, zea mays (corn) starch, sodium hyaluronate. May contain: red 7 lake, red 27 lake, iron oxides, mica, yellow 5 lake, titanium dioxide, red 6 lake, isononyl isononanoate, talc, isopropyl myristate, blue 1 lake, carmine, isopropyl titanium triisostearate, triethoxycaprylylsilane, stearalkonium hectorite, C9-15 fluoroalcohol phosphate, polyhydroxystearic acid, propylene carbonate.
SPL UNCLASSIFIED SECTION
Dist. by Ventura Corporation, Ltd.
San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 4 g Tube Carton
ēsika
Maximum Color
Lipstick SPF 18
4 g e (.14 oz.)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13537-442-02 | 2025-04-24 | C162847 | 48780-1 | 9855d018-e0f0-cd31-e053-dbdaa90ab51a | ēsika Maximum Color Lipstick SPF 18 |
| 13537-442-02 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e0f0-cd31-e053-dbdaa90ab51a | ēsika Maximum Color Lipstick SPF 18 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | 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 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 1 | |
| D&C RED NO. 6 | INACTIVE INGREDIENT | 481744AI4O | 1 | |
| D&C RED NO. 7 | INACTIVE INGREDIENT | ECW0LZ41X8 | 1 | |
| diisopropyl dilinoleate | INACTIVE INGREDIENT | 5323S7S2LR | 1 | |
| ethylhexyl palmitate | INACTIVE INGREDIENT | 2865993309 | 1 | |
| ethylparaben | INACTIVE INGREDIENT | 14255EXE39 | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| high density polyethylene | INACTIVE INGREDIENT | UG00KM4WR7 | 1 | |
| hyaluronate sodium | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| isobutylparaben | INACTIVE INGREDIENT | 0QQJ25X58G | 1 | |
| isononyl isononanoate | INACTIVE INGREDIENT | S4V5BS6GCX | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| isopropyl titanium triisostearate | INACTIVE INGREDIENT | 949E3KBJ1I | 1 | |
| maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | 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 | |
| polyglyceryl-2 dipolyhydroxystearate | INACTIVE INGREDIENT | 9229XJ4V12 | 1 | |
| propylene carbonate | INACTIVE INGREDIENT | 8D08K3S51E | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| shea butter | INACTIVE INGREDIENT | K49155WL9Y | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| triethoxycaprylylsilane | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| yellow wax | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- esika Maximum Color Lipstick SPF 18
- OCTINOXATE and Oxybenzone
- OCTINOXATE
- Oxybenzone
- diisopropyl dilinoleate
- ethylhexyl palmitate
- carnauba wax
- high density polyethylene
- shea butter
- silicon dioxide
- octyldodecanol
- water
- phenoxyethanol
- microcrystalline wax
- petrolatum
- methylparaben
- butylated hydroxytoluene
- cholesterol
- butylparaben
- ethylparaben
- candelilla wax
- yellow wax
- cetostearyl alcohol
- cetearyl glucoside
- polyglyceryl-2 dipolyhydroxystearate
- isobutylparaben
- propylparaben
- maltodextrin
- starch, corn
- hyaluronate sodium
- D&C RED NO. 7
- D&C RED NO. 27
- mica
- FD&C YELLOW NO. 5
- titanium dioxide
- D&C RED NO. 6
- isononyl isononanoate
- talc
- isopropyl myristate
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13537-442 | 13537-442-01, 13537-442-02 |
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 |
|---|---|---|---|---|---|---|
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | GRANULE, FOR SUSPENSION / ORAL | 952 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TOPICAL | 7 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | DROPS / AURICULAR (OTIC) | NA | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| talc | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| petrolatum | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CONCENTRATE / ORAL | 2.5 mg/5ml | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM / TRANSDERMAL | 58.08 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| cholesterol | CHOLESTEROL | 97C5T2UQ7J | OINTMENT / TOPICAL | 5 %w/w | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SPRAY / TOPICAL | 3665 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| high density polyethylene | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | OINTMENT / TOPICAL | 94 %w/w | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EXTENDED RELEASE / ORAL | 3239 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / OPHTHALMIC | 0.02 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | TABLET, CHEWABLE / ORAL | 0.14 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SHAMPOO / TOPICAL | 0.03 %w/w | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / OPHTHALMIC | 0.01 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION / TOPICAL | 3 mg | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION, CONCENTRATE / ORAL | 0.1 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, EXTENDED RELEASE / ORAL | 0.03 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / TOPICAL | 0.06 %w/w | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL, METERED / TRANSDERMAL | 50 mg | ||
| phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CONCENTRATE / BUCCAL | NA | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL / TOPICAL | 9.3 %w/w | ||
| petrolatum | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| cholesterol | CHOLESTEROL | 97C5T2UQ7J | LOTION / TOPICAL | 20 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| cholesterol | CHOLESTEROL | 97C5T2UQ7J | INJECTABLE, LIPOSOMAL / INFILTRATION | 0.47 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| candelilla wax | CANDELILLA WAX | WL0328HX19 | TABLET, EXTENDED RELEASE / ORAL | 3 mg | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | SUSPENSION / ORAL | 6040 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 |
|---|---|---|---|---|---|---|
| 3389ac0a-5f7e-b128-e063-6394a90a8012 | 86a34dea-7244-446e-8fa8-3fc11aa7a33a | 2025-04-24 | Warnings | 86a34dea-7244-446e-8fa8-3fc11aa7a33a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.