Indications and uses
Helps prevent sunburn.
OCTINOXATE and OXYBENZONE
- Manufacturer
- Ventura International LTD | Bel Star S.A. (Colombia)
- Effective date
- 2017-11-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:09:44
Label at a glance#
ProductPRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 1) - BROWN
Active ingredientOCTINOXATE, OXYBENZONE
Label structure20 sections
Dosage and administration
Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor
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 Ingredients | Purpose |
|---|---|
| Octinoxate 5.00 % | Sunscreen |
| Oxybenzone 2.00 % | 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 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
- 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.
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor
Other information
- Protect the product in this container from excessive heat and direct sun.
Inactive ingredients
WATER, CYCLOMETHICONE, CYCLOPENTASILOXANE, TALC, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, PISUM SATIVUM (PEA) EXTRACT, PEG-12 DIMETHICONE CROSSPOLYMER, HEXYL LAURATE, ISOSTEARYL NEOPENTANOATE, DISTEARDIMONIUM HECTORITE, CYCLOHEXASILOXANE, HYDROXYACETOPHENONE, ROSA CENTIFOLIA FLOWER WATER, SODIUM CHLORIDE, PHENOXYETHANOL, MANNITOL, DIMETHICONE, PROPYLENE CARBONATE, PROPYLENE GLYCOL, OCTYLDODECANOL, BUTYLENE GLYCOL, DIMETHICONOL, CAPRYLYL GLYCOL, CETEARYL DIMETHICONE CROSSPOLYMER, TOCOPHERYL ACETATE, CHLORPHENESIN, MICROCRYSTALLINE WAX, POLYMETHYLSILSESQUIOXANE, PETROLATUM, PHOSPHOLIPIDS, CYCLODEXTRIN, CHOLESTEROL, YEAST EXTRACT, EUPHORBIA CERIFERA (CANDELILLA) WAX, BEESWAX, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA (CARNAUBA ) WAX, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS, DISODIUM SUCCINATE. MAY CONTAIN: TITANIUM DIOXIDE, METHICONE, IRON OXIDES.
SPL UNCLASSIFIED SECTION
U.S.A.: Dist. by Ventura Int Ltd. DBA Belcorp
USA, Miami, FL 33126.
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 1) - BROWN
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 2) - BROWN
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 3) - BROWN
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 4) - BROWN
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 5) - BROWN
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 6) - BROWN
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 1) - PINK
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 2) - PINK
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 3) - PINK
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 4) - PINK
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 5) - PINK
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 6) - PINK
ésika
PRO
Hydro-Nutritive
Foundation SPF 15
30 ml e (1 fl.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 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 1 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CETEARYL GLUCOSIDE | INACTIVE INGREDIENT | 09FUA47KNA | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| CHOLESTEROL | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| CYCLOMETHICONE | INACTIVE INGREDIENT | NMQ347994Z | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| CYCLOMETHICONE 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DISTEARDIMONIUM HECTORITE | INACTIVE INGREDIENT | X687XDK09L | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| HEXYL LAURATE | INACTIVE INGREDIENT | 4CG9F9W01Q | 1 | |
| ISOSTEARYL NEOPENTANOATE | INACTIVE INGREDIENT | 411THY156Q | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | 1 | |
| OLIVE OIL | INACTIVE INGREDIENT | 6UYK2W1W1E | 1 | |
| PEA | INACTIVE INGREDIENT | W4X7H8GYFM | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE | INACTIVE INGREDIENT | 9229XJ4V12 | 1 | |
| POLYGLYCERYL-4 ISOSTEARATE | INACTIVE INGREDIENT | 820DPX33S7 | 1 | |
| PROPYLENE CARBONATE | INACTIVE INGREDIENT | 8D08K3S51E | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| ROSA CENTIFOLIA FLOWER OIL | INACTIVE INGREDIENT | H32V31VMWY | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| SODIUM SUCCINATE ANHYDROUS | INACTIVE INGREDIENT | V8ZGC8ISR3 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| YEAST, UNSPECIFIED | INACTIVE INGREDIENT | 3NY3SM6B8U | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 1) - BROWN
- OCTINOXATE and OXYBENZONE
- OCTINOXATE
- OXYBENZONE
- WATER
- CYCLOMETHICONE
- CYCLOMETHICONE 5
- TALC
- POLYGLYCERYL-4 ISOSTEARATE
- PEA
- HEXYL LAURATE
- ISOSTEARYL NEOPENTANOATE
- DISTEARDIMONIUM HECTORITE
- CYCLOMETHICONE 6
- ROSA CENTIFOLIA FLOWER OIL
- SODIUM CHLORIDE
- PHENOXYETHANOL
- MANNITOL
- DIMETHICONE
- PROPYLENE CARBONATE
- PROPYLENE GLYCOL
- OCTYLDODECANOL
- BUTYLENE GLYCOL
- CAPRYLYL GLYCOL
- .ALPHA.-TOCOPHEROL ACETATE
- CHLORPHENESIN
- MICROCRYSTALLINE WAX
- PETROLATUM
- LECITHIN, SOYBEAN
- CHOLESTEROL
- YEAST, UNSPECIFIED
- CANDELILLA WAX
- YELLOW WAX
- CETOSTEARYL ALCOHOL
- CETEARYL GLUCOSIDE
- CARNAUBA WAX
- POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
- SODIUM SUCCINATE ANHYDROUS
- TITANIUM DIOXIDE
- FERRIC OXIDE RED
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 |
|---|---|---|---|---|---|---|
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| TALC | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PARENTERAL | 584 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / SOFT TISSUE | 26 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / OPHTHALMIC | 0.9 %w/v | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 105 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / ORAL | 7093 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SOLUTION / OPHTHALMIC | 0.9 %w/w | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / INTRAVENOUS | 15400 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 658 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, FILM COATED / ORAL | 0.8 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1800 mg | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | CREAM / TOPICAL | 160 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, CHEWABLE / ORAL | 20 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / TOPICAL | 3.1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVASCULAR | 0.86 %w/v | ||
| CHOLESTEROL | CHOLESTEROL | 97C5T2UQ7J | CREAM / VAGINAL | 0.3 %w/w | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 10.25 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| CHOLESTEROL | CHOLESTEROL | 97C5T2UQ7J | CREAM / TOPICAL | 1 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACARDIAC | 70 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / RECTAL | 32.4 mg | ||
| CHOLESTEROL | CHOLESTEROL | 97C5T2UQ7J | INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL | 7 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / ORAL | 148 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / TOPICAL | 0.23 %w/v | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAVENOUS | 2.5 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVESICAL | 351 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRA-ARTICULAR | 26 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER / RESPIRATORY (INHALATION) | NA | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBARACHNOID | 0.9 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 3053c2c0-d43f-9fba-e063-6394a90abd57 | dc73aa0d-a0a9-4946-9f3b-da0198748a7b | 2025-03-14 | Warnings | dc73aa0d-a0a9-4946-9f3b-da0198748a7b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.