SPF 50 UVA/UVB description, usages, side effects, indications, overdosage, supplying and lots more!

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SPF 50 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 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 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, ppg-12/smdi copolymer,

glycerin, peg-100 stearate, glyceryl stearate,

magnesium aluminum silicate, propylene glycol,

prunus armeniaca (apricot) kernel oil, sorbitan

stearate, bisabolol, xanthan gum,

sodium acrylate /sodium acryloyldimethyl taurate

copolymer, tocopheryl acetate, panthenol,

isohexadecane, retinyl palmitate, camellia

sinensis (green tea) leaf extract, tetrasodium edta,

dipotassium glycyrrhizate, maltodextrin, camellia

sinensis (white tea) leaf extract, polysorbate 80,

aspalathus linearis (rooibos) leaf extract,

methylisothiazolinone, phenoxyethanol, sodium

hydroxide, chlorphenesin.

SPF 50 UVA/UVB

SPF 50 UVA/UVB

ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51191-3015
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTOCRYLENE Octocrylene 8 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-100 STEARATE
PHENOXYETHANOL
.ALPHA.-BISABOLOL, (+/-)-
CHLORPHENESIN
XANTHAN GUM
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)
EDETATE SODIUM
METHYLISOTHIAZOLINONE
magnesium aluminum silicate
propylene glycol
Apricot Kernel Oil
SORBITAN MONOSTEARATE
SODIUM HYDROXIDE
.ALPHA.-TOCOPHEROL ACETATE
PANTHENOL
Isohexadecane
VITAMIN A PALMITATE
GREEN TEA LEAF
GLYCYRRHIZINATE DIPOTASSIUM
TEA LEAF
maltodextrin
polysorbate 80
ASPALATHUS LINEARIS LEAF

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51191-3015-1 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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