6 CREME 410 TEINTEE- octinoxate cream 
MULTALER & 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


Octinoxate 5% . . . . . . . . . . . . . . . . . Sunscreen

Uses • helps prevent sunburn • higher
SPF gives more sunburn protection • provides
minimal 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.

CREME SOLAIRE
PROTECTRICE TEINTEE
AUX EXTRAITS DE PLANTES

FAIBLE PROTECTION

Peaux sensibles

6 CREME 410 TEINTEE

For fair skin

LOW PROTECTION

TINTED PROTECTIVE SUN
CREAM WITH BOTANICALS

Crema solar protectora coloreada
con extractos de planta.
Protección baja.
Crema solare protettiva colorata agli estratti
di piante.
Protezione debole.
Getönte Sonnenschutzcreme mit
Pflanzenextrakten.
Niedriger Schutz.
Gekleurde beschermende zonnecreme
op basis van plantenextracten.
Lichte bescherming.

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.
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.

Inactive ingredients Aqua/water/eau,
cetyl alcohol, cucurbita pepo (pumpkin) seed
oil, paraffinum liquidum/mineral oil/huile
minerale, zea mays (corn) oil, tea stearate,
cera alba/beeswax/cire d’abeille, propylene
glycol, helianthus annuus (sunflower) seed oil,
glycine soja (soybean) oil, lavandula
angustifolia (lavender) oil, pelargonium
graveolens (geranium) leaf oil, rosmarinus
officinalis (rosemary) leaf oil, cupressus
sempervirens (cypress) oil, thymus vulgaris
(thyme) oil, PEG-35 castor oil, PEG-6
stearate, PEG-6 oleate, tocopheryl acetate
(vit. E: 0,2 %), diazolidinyl urea,
methylparaben, propylparaben, iron oxides
/CI 77499/CI 77491/CI 77492, linalool*,
limonene*, citronellol*, geraniol*, citral*,
coumarin*, benzyl benzoate*.

*Composants naturels d’huiles essentielles -
natural components of essential oils.

etui creme 410 IP6 teintee

6 CREME 410 TEINTEE 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51191-2013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MINERAL OIL (UNII: T5L8T28FGP)  
CORN OIL (UNII: 8470G57WFM)  
TROLAMINE (UNII: 9O3K93S3TK)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
SOYBEAN OIL (UNII: 241ATL177A)  
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
THYME OIL (UNII: 2UK410MY6B)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51191-2013-150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package02/15/201105/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/15/201105/11/2017
Labeler - MULTALER & CIE S.A.S (509613345)
Registrant - MULTALER & CIE S.A.S (509613345)
Establishment
NameAddressID/FEIBusiness Operations
MULTALER & CIE S.A.S509613345manufacture(51191-2013) , label(51191-2013)

Revised: 5/2017
 
MULTALER & CIE S.A.S