SPF 50 UVA/UVB- ensulizole, oxybenzone, avobenzone, octocrylene cream 
MULTALER ET CIE S.A.S.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredients Purpose

Ensulizole 3%     {

Oxybenzone 5% {  Sunscreen

Avobenzone 3% {

Octocrylene 8%  {

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

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 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.

Box SPF 50

SPF 50 UVA/UVB 
ensulizole, oxybenzone, avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51191-3015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
EDETATE SODIUM (UNII: MP1J8420LU)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
PANTOLACTONE, (+/-)- (UNII: IID733HD2M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51191-3015-150 g in 1 TUBE; Type 0: Not a Combination Product04/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/15/2013
Labeler - MULTALER ET CIE S.A.S. (509613345)
Registrant - MULTALER ET CIE S.A.S. (509613345)
Establishment
NameAddressID/FEIBusiness Operations
MULTALER ET CIE S.A.S.509613345manufacture(51191-3015) , label(51191-3015)

Revised: 5/2021
Document Id: b0368e3c-741f-4b9d-bd29-4fdc17d6a51a
Set id: 574dc839-1a61-4f2d-aefd-a2cda65f6a2a
Version: 8
Effective Time: 20210531
 
MULTALER ET CIE S.A.S.