SPF 40 UVA/UVB

Dosage form: cream
Ingredients: HOMOSALATE 4g in 100g, TITANIUM DIOXIDE 11g in 100g, OCTINOXATE 7.5g in 100g, OCTISALATE 5g in 100g
Labeler: MULTALER & CIE S.A.
NDC Code: 51191-2015

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.

DRUG FACTS


Active ingredients                               Purpose

Homosalate 10%              }
Octinoxate 7,5%               }
Octisalate 5%                   } . . . . . .  . Sunscreen
Titanium dioxide 11%       }

Visage et
zones sensibles

CRÈME SOLAIRE
AUX POLYPHÉNOLS DE THÉ
RÉSISTANT À L’EAU
SANS PARFUM

HAUTE PROTECTION

SPF 40 UVA/UVB

HIGH PROTECTION

FRAGRANCE FREE
WATER RESISTANT
SUN CREAM
WITH TEA POLYPHENOLS

Face and
sensitive areas

Crema solar con polifenoles de té.
Rostro y zonas sensibles. Alta protección.
Resistente al agua. Sin perfume.

Crema solare ai polifenoli di té.
Viso e zone sensibili. Alta protezione.
Resistente all’acqua. Senza profumo.

Sonnencreme mit teepolyphenolen. Gesicht
und empfindliche Zonen. Hoher Schutz.
Wasserfest. Parfumfrei.

Zonnecreme met polyphenolen uit thee.
Gezicht en gevoelige plekken. Hoge
bescherming. Waterbestendig.
Ongeparfumeerd.

Aide à prévenir les coups de soleil. Un SPF
supérieur protège davantage. Appliquer
généreusement avant toute exposition.
Appliquer de nouveau le produit après le
séchage à la serviette, la baignade, ou après
avoir transpiré. Pour les enfants de moins de 6
mois, consulter un médecin. Non comédogène.
Tolérance testée sous contrôle dermatologique
Avertissement : Pour usage externe seulement.
Eviter tout contact avec les yeux. En cas de
contact, rincer abondamment. 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.

Uses • helps prevent sunburn • higher
SPF gives more sunburn protection • retains
SPF after 40 minutes of activity in the water.
• provides high protection against sunburn.

Warnings
For external use only.
When using this product keep out of eyes.
Rinse with water to remove.
Stop use and ask a doctor if rash or irritation
develops and lasts.
Keep out of reach of children. If swallowed,
get medical help or contact a poison Control
Center right away.

Directions
• Apply generously before sun exposure.
• Reapply as needed or after towel drying,
swimming or perspiring.
• Children under 6 months of age: ask a doctor.

Inactive ingredients Aqua/water/eau,
C12-15 alkyl benzoate, cyclomethicone,
glycerin, glyceryl stearate, PEG-100 stearate,
isononyl isononanoate, PPG-12/SMDI
copolymer, polyhydroxystearic acid, aluminum
stearate, alumina, magnesium aluminum
silicate, propylene glycol, prunus armeniaca
(apricot) kernel oil, sorbitan stearate,
bisabolol, camelia sinensis (green tea) leaf
extract, camelia sinensis (white tea) leaf
extract, aspalathus linearis (rooibos) leaf
extract, citric acid, tocopheryl acetate (vit. e :
0,2 %), panthenol (vit. b5), sodium
acrylate/acryloyldimethyltaurate copolymer,
xanthan gum, retinyl palmitate (vit. a),
isohexadecane, dipotassium glycyrrhizate,
tetrasodium edta, maltodextrin,
phenoxyethanol, chlorphenesin, sodium
dehydroacetate, sodium benzoate.

SPF 40 UVA/UVB 
titanium dioxide, octinoxate, octisalate, homosalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51191-2015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE4 g  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE ) TITANIUM DIOXIDE 11 g  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALKYL (C12-15) BENZOATE 
CYCLOMETHICONE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
POLYOXYL 100 STEARATE 
ISONONYL ISONONANOATE 
ALUMINUM STEARATE  
ALUMINUM OXIDE 
MAGNESIUM ALUMINUM SILICATE 
APRICOT KERNEL OIL 
PROPYLENE GLYCOL 
LEVOMENOL  
SORBITAN MONOSTEARATE 
GREEN TEA LEAF 
CITRIC ACID 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
TEA LEAF 
EDETATE SODIUM 
PHENOXYETHANOL 
CHLORPHENESIN 
PANTHENOL 
XANTHAN GUM 
VITAMIN A PALMITATE 
ISOHEXADECANE 
GLYCYRRHIZINATE DIPOTASSIUM 
MALTODEXTRIN 
SODIUM DEHYDROACETATE 
SODIUM BENZOATE 
Packaging
#Item CodePackage Description
1NDC:51191-2015-150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/15/2011
Labeler - MULTALER & CIE S.A. (509613345)
Registrant - MULTALER & CIE S.A. (509613345)
Establishment
NameAddressID/FEIOperations
MULTALER & CIE S.A.509613345manufacture

Revised: 07/2011
 
MULTALER & CIE S.A.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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