FDA.reportPublic FDA data

OCTINOXATE and OXYBENZONE

Manufacturer
Ventura Corporation LTD | Bel Star S.A. (Colombia)
Effective date
2015-10-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:30:17

Label at a glance#

ProductNATURAL CARE CONCHA DE NACAR and ROSA MOSQUETA CREMA FACIAL FPS 15 PARA UNA APARIENCIA MAS CLARA FM
Active ingredientOCTINOXATE, OXYBENZONE
Label structure9 sections

Storage and handling

Proteja el producto del calor excesivo y del sol directo.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Información del medicamento

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Ingredientes activosPropósito
OCTINOXATE (7.5%)Protector Solar
OXYBENZONE(4.5%)Protector Solar

Uso

INDICATIONS & USAGE SECTION

  • Ayuda a prevenir quemaduras solares

Advertencias

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

  • Alerta de Cáncer en la piel / envejecimiento de la piel : Pasar tiempo bajo el sol incrementa el riesgo de cáncer y envejecimiento prematuro de la piel. Este producto ha demostrado que unicamente ayuda a prevenir las quemaduras solares pero no previene el cáncer a la piel ni el envejecimiento prematuro de la misma.
  • Sólo para uso externo.

OTC - DO NOT USE SECTION

  • No usar en piel dañada o lastimada.

OTC - WHEN USING SECTION

  • Cuando use este producto mantener alejado de los ojos. Enjuagar con agua para eliminar.

OTC - STOP USE SECTION

  • Detenga su uso y consulte al doctor si sucede enrojecimiento.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Mantener fuera del alcance de los niños. Si es ingerido obtener ayuda médica o contactar al centro de Control de Envenenamiento inmediatamente

Instrucciones

DOSAGE & ADMINISTRATION SECTION

  • Aplicar generosamente y uniformemente 15 minutos antes de la exposición al sol.
  • Reaplicar por lo menos cada dos horas.
  • Use un protector solar resistente al agua si usted nada o suda.
  • Niños menores a 6 meses de edad: Consulte al médico

Otra información

STORAGE AND HANDLING SECTION

  • Proteja el producto del calor excesivo y del sol directo.

Ingredientes inactivos

INACTIVE INGREDIENT SECTION

WATER, GLYCERYL STEARATE, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, PEG-100 STEARATE, CETYL ALCOHOL, DICAPRYLYL CARBONATE, PROPYLENE GLYCOL, GLYCERIN, CYCLOHEXASILOXANE, HYDROXYACETOPHENONE, DIMETHICONE, TITANIUM DIOXIDE, PAPAIN, TRIETHANOLAMINE, CAPRYLYL GLYCOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, 1,2-HEXANEDIOL, SODIUM LACTATE, CASTORYL MALEATE, FRAGRANCE, BUTYLENE GLYCOL, TETRASODIUM EDTA, CALCIUM PANTOTHENATE, ARCTOSTAPHYLOS UVA URSI LEAF EXTRACT, XANTHAN GUM, ROSA MOSCHATA SEED OIL, UREA, MAGNESIUM LACTATE, ETHYLHEXYLGLYCERIN, POTASSIUM LACTATE, ALANINE, MAGNESIUM CHLORIDE, PROLINE, SERINE, SODIUM CITRATE, MOTHER OF PEARL EXTRACT.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 60 g Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

naturalcare

concha de nácar
& rosa mosqueta

crema facial FPS 15
para una apariencia más clara FM

Net Wt 2.1 oz. e (60 g)
ésika

Principal Display Panel - 60 g Bottle Box
Principal Display Panel - 60 g Bottle Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13537-386-022025-04-25C16284748780-19d75b9d0-228a-f424-e053-dadaa90a57ceNATURAL CARE CONCHA DE NÁCAR & ROSA MOSQUETA CREMA FACIAL FPS 15 PARA UNA APARIENCIA MÁS CLARA FM
13537-386-022020-01-31C16284748780-19d75b9d0-228a-f424-e053-dadaa90a57ceNATURAL CARE CONCHA DE NÁCAR & ROSA MOSQUETA CREMA FACIAL FPS 15 PARA UNA APARIENCIA MÁS CLARA FM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G1
ALANINEINACTIVE INGREDIENTOF5P57N2ZX1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
ARCTOSTAPHYLOS UVA-URSI LEAFINACTIVE INGREDIENT3M5V3D1X361
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3D1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CASTORYL MALEATEINACTIVE INGREDIENTV5B97ZYP2F1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA1
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O1
MAGNESIUM LACTATEINACTIVE INGREDIENTMT6QI8324A1
PAPAININACTIVE INGREDIENTA236A06Y321
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
POTASSIUM LACTATEINACTIVE INGREDIENT87V1KMK4QV1
PROLINEINACTIVE INGREDIENT9DLQ4CIU6V1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
ROSA MOSCHATA SEED OILINACTIVE INGREDIENTT031ZE559T1
SERINEINACTIVE INGREDIENT452VLY94021
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QT1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
UREAINACTIVE INGREDIENT8W8T17847W1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13537-38613537-386-01, 13537-386-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CYCLOMETHICONE 50THT5PCI0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PEG-100 STEARATEYD01N1999RIACT
CETYL ALCOHOL936JST6JCNIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
CYCLOMETHICONE 6XHK3U310BAIACT
DIMETHICONE92RU3N3Y1OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PAPAINA236A06Y32IACT
TROLAMINE9O3K93S3TKIACT
CAPRYLYL GLYCOL00YIU5438UIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
SODIUM LACTATETU7HW0W0QTIACT
CASTORYL MALEATEV5B97ZYP2FIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
EDETATE SODIUMMP1J8420LUIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36IACT
XANTHAN GUMTTV12P4NEEIACT
ROSA MOSCHATA SEED OILT031ZE559TIACT
UREA8W8T17847WIACT
MAGNESIUM LACTATEMT6QI8324AIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM LACTATE87V1KMK4QVIACT
ALANINEOF5P57N2ZXIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
PROLINE9DLQ4CIU6VIACT
SERINE452VLY9402IACT
SODIUM CITRATE1Q73Q2JULRIACT

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 6 · 333 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUEMULSION / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
UREAUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii candidate
7 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSUSPENSION / AURICULAR (OTIC)0.06 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / SUBLINGUAL1.23 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUTABLET / ORAL5 mgExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OINJECTION, SUSPENSION / INTRAVITREAL0.03 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION / INTRAMUSCULAR0.01 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM LACTATESODIUM LACTATETU7HW0W0QTGEL / TOPICAL4 mgExact identifier — unii candidate
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 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
339e5f17-6251-062d-e063-6294a90abc524bc25e8a-aafb-485e-a445-4ff4e4f0d0142025-04-25WarningsExact identifier
spl set id: 4bc25e8a-aafb-485e-a445-4ff4e4f0d014

Reported adverse events (FAERS/openFDA)#

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