ULTRAPROTECTION- octinoxate, titanium dioxide 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

Titanium dioxide................................5%
Octinoxate.......................................7.5%

CREME SOLAIRE ANTI-AGE
AUX EXTRAITS
DE PLANTES ET DE FRUITS

PROTECTION MODEREE

ULTRA
PROTECTION

MODERATE PROTECTION

AGE-FREE SOLAR BLOCK
WITH BOTANICALS
AND FRUIT EXTRACTS
SPF 25
UVA-UVB-IR

Crema solar anti-arrugas con extractos de
plantas y frutas.
Protección moderada.

Crema solare anti-rughe con estratti di piante
e di frutti.
Protezione moderata.

Anti-Hautalterung Sonnencreme mit Pflanzenund
Früchteextrakten.
Mässiger Schutz.

Anti-rimple zonnecreme met plantaardigeen
fruitextracten.
Matige 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. 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 • provides
moderate 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, PPG-12/SMDI
copolymer, ceteareth-20, glyceryl stearate,
PEG-6 stearate, cyclomethicone, PEG-32
stearate, polyacrylamide, glycerin, triticum
vulgare (wheat) germ oil, vaccinium myrtillus
(bilberry) extract, acer saccharinum (sugar
maple) extract, saccharum officinarum (sugar
cane) extract, citrus aurantium dulcis (orange)
extract, citrus medica limonum (lemon)
extract, hydrolyzed sweet almond protein, zea
mays (corn) oil, helianthus annuus (sunflower)
seed oil, glycine soja (soybean) oil, propylene
glycol, mica, alumina, aluminium stearate,
mimosa tenuiflora (bark) extract,
polyhydroxystearic acid, sodium polyacrylate,
tocopheryl acetate (vit. e: 0,2 %), urea,
laureth-7, melanin, allantoin, lavandula
angustifolia (lavender) oil, pelargonium
graveolens (geranium) leaf oil, rosmarinus
officinalis (rosemary) leaf oil, cupressus
sempervirens (cypress) oil, thymus vulgaris
(thyme) oil, hydrolyzed gadidae protein,
phenoxyethanol, methylparaben,
propylparaben, methylisothiazolinone,
tetrasodium edta, citric acid, linalool*,
citronellol*, geraniol*, limonene*, citral*.

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

etui ultraprotection

ULTRAPROTECTION 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51191-2016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.98 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
WHEAT GERM OIL (UNII: 14C97E680P)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MICA (UNII: V8A1AW0880)  
CORN OIL (UNII: 8470G57WFM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
UREA (UNII: 8W8T17847W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
LAURETH-7 (UNII: Z95S6G8201)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALLANTOIN (UNII: 344S277G0Z)  
SOYBEAN OIL (UNII: 241ATL177A)  
ORANGE (UNII: 5EVU04N5QU)  
EDETATE SODIUM (UNII: MP1J8420LU)  
LEMON (UNII: 24RS0A988O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SUCROSE (UNII: C151H8M554)  
BILBERRY (UNII: 9P2U39H18W)  
MIMOSA BARK EXTRACT (UNII: 515MQE449I)  
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
THYME OIL (UNII: 2UK410MY6B)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51191-2016-150 g in 1 TUBE; Type 0: Not a Combination Product02/15/201105/11/2017
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(51191-2016) , label(51191-2016)

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