SPF 50 UVA/UVB

Manufacturer
MULTALER ET CIE S.A.S.
Effective date
2021-05-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:44:12

Label at a glance#

ProductSPF 50 UVA/UVB
Active ingredientOCTOCRYLENE, OXYBENZONE, AVOBENZONE, ENSULIZOLE
Label structure2 sections

Label contents#

Full prescribing information#

DRUG FACTS

WARNINGS AND PRECAUTIONS SECTION

Active ingredients Purpose

Ensulizole 3%     {

Oxybenzone 5% {  Sunscreen

Avobenzone 3% {

Octocrylene 8%  {

DESCRIPTION SECTION

SOLAR CARE

SPF 50 UVA/UVB

BROAD SPECTRUM

CREME SOLAIRE

Haute Protection

aux 3 thés

SUNSCREEN CREAM

High protection

with 3 teas

Crème solaire aux 3 thés.

Haute protection SPF 50.

Sunscreen cream with 3 teas.

High protection SPF 50

Crema solar con 3 tés.

Alta proteccion SPF 50.

Sonnencreme mit dreierlei Tee.

Hoher Schutz SPF 50.

Crema solare con 3 tè. 

Alta Protezione SPF 50.

Zonnencrème met 3 theesorten.

Hoge Bescherming SPF 50.

Creme solar à base de 3 chas.

Alta protecçao SPF 50.

Aide à prévenir les coups de soleil.

Appliquer généreusement avant toute

exposition. Renouveler fréquemment

et généreusement l'application pour

maintenir la protection, surtout après

avoir transpiré, avoir nagé ou s'être

essuyé. Pour les enfants de moins de

6 mois, consulter un médecin.

Avertissement : Pour usage externe

seulement. Eviter tout contact avec les

yeux. En cas de contact, rincer abon-

damment. Cesser d'utiliser et consulter

un médecin en cas d'irritations ou

d'éruptions cutanées. Tenir hors de la

portée des enfants. En cas d'absorption,

consulter un médecin ou le centre

anti-poisons.

Recommandations : Eviter de trop vous

exposer aux heures les plus chaudes

de la journée. Ne restez pas trop long-

temps au soleil. même si vous utilisez

un produit de protection solaire. Pro-

tégez-vous avec un chapeau, un t-shirt

et des lunettes de soleil. N'exposez pas

les bébés et les jeunes enfants directe-

ment au soleil. La surexposition au soleil

est une menace sérieuse

pour la santé.

CONTIENT BENZOPHENONE-3

CONTAINS BENZOPHENONE-3

NON COMEDOGENE

NON COMEDOGENIC

TOLERANCE TESTEE SOUS CONTROLE DERMATOLOGIQUE

TOLERANCE TESTED BY DERMATOLOGISTS

WARNINGS AND PRECAUTIONS SECTION

Uses • hels prevent sunburn.

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes.

Rinse with water to remove.

Keep out of reach of children. If swallowed,

get medical help or contact poison control

center right away.

Directions

• Apply liberally 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or

  sweating. Reapply at least every 2 hours.

  Children under 6 months : 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

sprectrum SPF value of 15 or higher and

other sun protection measures including:

• limit time in the sun, especially from 10 a.m-2p.m

• wear long-sleeved shirts, pants, and sunglasses.

Other information

• Protect this product from excessive heat and

direct sun.

INACTIVE INGREDIENT SECTION

Inactive ingredients

AQUA/WATER/EAU,
C12-15 ALKYL BENZOATE,
GLYCERYL STEARATE,
PPG-12/SMDI COPOLYMER,
GLYCERIN,
PEG-100 STEARATE,
TROMETHAMINE,
MAGNESIUM ALUMINUM SILICATE,
PROPYLENE GLYCOL,
PRUNUS ARMENIACA (APRICOT) KERNEL OIL,
SORBITAN STEARATE,
CAPRYLYL GLYCOL,
BISABOLOL,
DIMETHICONE,
CHLORPHENESIN,
XANTHAN GUM,
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,
TOCOPHERYL ACETATE,
PANTHENOL,
CAPRYLHYDROXAMIC ACID,
CAMELLIA SINENSIS LEAF EXTRACT,
ISOHEXADECANE,
TETRASODIUM EDTA,
RETINYL PALMITATE,
DIPOTASSIUM GLYCYRRHIZATE,
MALTODEXTRIN,
POLYSORBATE 80,
ASPALATHUS LINEARIS LEAF EXTRACT,
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,
PANTOLACTONE,
TOCOPHEROL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box SPF 50Box SPF 50

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51191-3015-12021-05-31C16284748780-1ba0f9c33-5df3-a910-e053-dadaa90a0b85574dc839-1a61-4f2d-aefd-a2cda65f6a2a
51191-3015-12021-01-29C16284748780-1ba0f9c33-5df3-a910-e053-dadaa90a0b85574dc839-1a61-4f2d-aefd-a2cda65f6a2a

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX4
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W424
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM4
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y4
AVOBENZONEACTIVE MOIETYG63QQF2NOX4
ENSULIZOLEACTIVE MOIETY9YQ9DI1W424
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM4
OXYBENZONEACTIVE MOIETY95OOS7VE0Y4
.ALPHA.-BISABOLOL, (+/-)-INACTIVE INGREDIENT36HQN158VC4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L04
APRICOT KERNEL OILINACTIVE INGREDIENT54JB35T06A4
ASPALATHUS LINEARIS LEAFINACTIVE INGREDIENTH7UGK1GJCU4
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ4
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ4
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE44
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX4
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B04
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E4
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D4
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA4
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R4
PEG-8/SMDI COPOLYMERINACTIVE INGREDIENTCCX72L6NY64
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)INACTIVE INGREDIENT1DXE3F3OZX4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I4
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X4
TEA LEAFINACTIVE INGREDIENTGH42T47V244
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC4
WATERINACTIVE INGREDIENT059QF0KO0R4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE4

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
51191-301551191-3015-1

Ingredients#

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

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

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 9 · 525 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4GRANULE, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, COATED / ORALNAExact identifier — unii candidate
174 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / RECTAL315 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / AURICULAR (OTIC)13 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION, SOLUTION / INTRAVENOUS0.04 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPOWDER / ORAL66 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IDROPS / OPHTHALMICNAExact identifier — unii candidate
174 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICONCENTRATE / ORAL10 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM, AUGMENTED / TOPICAL6 mgExact identifier — unii candidate
174 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XAEROSOL, FOAM / TOPICAL0.55 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCONCENTRATE / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCAPSULE / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / AURICULAR (OTIC)0.2 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IOINTMENT / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / ORAL9120 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 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
1c5893cf-8047-5f85-e063-6294a90a55e5574dc839-1a61-4f2d-aefd-a2cda65f6a2a2024-07-03WarningsExact identifier
spl set id: 574dc839-1a61-4f2d-aefd-a2cda65f6a2a

Reported adverse events (FAERS/openFDA)#

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