SPF 25 UVA/UVB description, usages, side effects, indications, overdosage, supplying and lots more!

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SPF 25 UVA/UVB

MULTALER ET CIE S.A.S.
MULTALER ET CIE S.A.S.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

Active ingredients Purpose

Ensulizole 3%     {

Oxybenzone 5% {  Sunscreen

Avobenzone 3% {

Octocrylene 6%  {

SOLAR CARE

SPF 25 UVA/UVB

BROAD SPECTRUM

CREME SOLAIRE

Protection moyenne

aux extraits de plantes

SUNSCREEN CREAM

Medium protection

with plant extracts

Crème solaire anti-âge aux extraits

de plantes et de fruits. Protection

moyenne SPF 25.

Age free sunscreen cream with

botanicals and fruit extracts.

Medium protection SPF 25.

Crema solar anti-arrugas con

extractos de plantas y frutas.

Proteccion media SPF 25.

Anti-aging Sonnencreme mit

Pflanzen- und Fruchtextrakten.

Mittlerer Schutz SPF 25.

Crema solare anti-età agli estratti di

piante e di frutta. Protezione media

SPF 25.

Antiageing Zonnencrème met

planten- en fruitextracten.

Gemiddelde Bescherming SPF 25.

Creme solar antienvelhecimento à

base de extractos de plantas e frutos.

Protecçao média SPF 25.

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 DE L'OXYBENZONE

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, propylene glycol dicaprylate/dicaprate,

glycerin, cetyl alcohol, peg-75 stearate, triticum vulgare

(wheat) germ oil, zea mays (corn) oil, dimethicone,

ceteth-20, steareth-20, acer saccharum (sugar maple)

extract, vaccinium myrtillus (bilberry) fruit extract,

saccharum officinarum(sugar cane) extract/extrait de

canne a sucre, xanthan gum, helianthus annuus

(sunflower) seed oil, tocopheryl acetate, hydrolyzed soy

protein, bisabolol, glycine soja (soybean) oil, mimosa

tenuiflora bark extract, hydrolyzed sweet almond

protein, citrus limon fruit extract/citrus medica limonum

(lemon) fruit extract, lavandula angustifolia (lavender)

oil, pelargonium graveolens (geranium) leaf oil,

rosmarinus officinalis (rosemary) leaf oil, cupressus

sempervirens (cypress) oil, thymus vulgaris (thyme)

flower/leaf oil, citrus aurantium dulcis (orange) fruit

extract, sodium hydroxide, chlorphenesin,

methylisothiazolinone, phenoxyethanol, sodium

dehydroacetate, sodium benzoate, tetrasodium edta,

linalool*, citronellol*, geraniol*, limonene*.

*composants naturels d'huiles essentielles - natural com-

ponents of essentials oils

SPF 25 UVA/UVB

SPF 25 UVA/UVB

ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51191-3016
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTOCRYLENE Octocrylene 6 g
OXYBENZONE OXYBENZONE 5 g
AVOBENZONE AVOBENZONE 3 g
Ensulizole Ensulizole 3 g

Inactive Ingredients

Ingredient Name Strength
water
C12-15 ALKYL BENZOATE
GLYCERIN
PEG-8/SMDI COPOLYMER
GLYCERYL MONOSTEARATE
peg-75 stearate
Propylene Glycol Dicaprylate/Dicaprate
CETYL ALCOHOL
PHENOXYETHANOL
.ALPHA.-BISABOLOL, (+/-)-
CHLORPHENESIN
XANTHAN GUM
EDETATE SODIUM
METHYLISOTHIAZOLINONE
SODIUM HYDROXIDE
.ALPHA.-TOCOPHEROL ACETATE
WHEAT GERM OIL
CORN OIL
DIMETHICONE
CETETH-20
Steareth-20
SUGARCANE
ACER SACCHARUM SAP
BILBERRY
SUNFLOWER OIL
SOY PROTEIN
SOYBEAN OIL
MIMOSA TENUIFLORA BARK
ALMOND
LEMON
LAVENDER OIL
ROSMARINUS OFFICINALIS FLOWERING TOP OIL
CUPRESSUS SEMPERVIRENS LEAF OIL
THYME OIL
ORANGE
SODIUM DEHYDROACETATE
SODIUM BENZOATE
PELARGONIUM GRAVEOLENS FLOWER OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51191-3016-1 50 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-04-15


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