SPF 20 UVA/UVB description, usages, side effects, indications, overdosage, supplying and lots more!

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SPF 20 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

Homosalate 10% {

Octinoxate 7.5% {

Octisalate 5% { Sunscreen

Oxybenzone 5% {

Avobenzone 3% {

Octocrylene 2.7% {

SOLAR CARE

SPF 20 UVA/UVB

BROAD SPECTRUM

SPRAY SOLAIRE

Protection moyenne

aux polyphénols d'olive

SUNSCREEN SPRAY

Medium protection

with olive polyphenols

Spray solaire aux polyphénols d'olive.

Visage et corps. Protection moyenne

SPF 20

Sunscreen spray with olive polyphenols.

Face and body. Medium protection

SPF 20

Spray solar con polifenoles de oliva.

Cara y cuerpo. Proteccion media SPF 20

Sonnenspray mit Olivenpolyphenolen.

Gesicht und Körper. Mittlerer Schutz

SPF 20

Spray solare ai polifenoli de oliva. Viso e

corpo. Protezione media SPF 20

Zonnenspray met polyfenolen uit

olijven. Gelaat en lichaam. Gemiddelde

bescherming SPF 20

Spray solar à base de poefenois de

azeitona. Rosto e corpo. Protecçao

média SPF 20

Aide à prévenir les coups de soleil. Appliquer

généreusement avant toute exposition.

Ne pas pulvériser directement sur le visage.

Pulvériser sur les mains puis appliquer sur

le visage. Renouveler fréquemment et

généreusement l'application pour main-

tenir 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 seule-

ment. 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.

Recommandations : Eviter de trop vous

exposer aux heures les plus chaudes de la

journée. Ne restez pas trop longtemps au

soleil. même si vous utilisez un produit de

protection solaire. Protégez-vous avec un

chapeau, un t-shirt et des lunettes de soleil.

N'exposez pas les bébés et les jeunes

enfants directement au soleil. La surexpo-

sition 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. When using this

product keep away from face to avoid

breathing it.

Keep out of reach of children. If swallowed,

get medical help or contact poison control

center right away.

Directions

• Spray liberally and spread evenly by hand

15 minutes before sun exposure.

• Do not spray directly into face. Spray on hands

then apply to face.

• 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,

Cyclomethicone, c12-15 alkyl benzoate,

Glycerin, ppg-12/smdi copolymer, propylene

glycol dicaprylate/dicaprate, lauryl glucoside,

polyglyceryl-2 dipolyhydroxystearate,

dimethicone crosspolymer, tocopheryl acetate

(vit. E : 0.5%), phenoxyethanol, bisabolol,

Chlorphenesin, xanthan gum, acrylates/c10-30

alkyl acrylate crosspolymer, tetrasodium edta,

lavandula angustifolia (lavender) oil,

biosaccharide gum-1, pelargonium graveolens

(geranium) leaf oil, manganese gluconate,

rosmarinus officinalis (rosemary) leaf oil,

cupressus sempervirens (cypress) oil, thymus

vulgaris (thyme) flower/leaf oil, citric acid,

sodium hydroxide, olea europaea (olive) fruit

extract, methylisothiazolinone, linalool *,

citronellol*, geraniol*, limonene*.

*composants naturels d'huile essentielle - natural

components of essentials oils.

SPF 20 UVA/UVB

SPF 20 UVA/UVB

HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51191-2046
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 10 g
OCTINOXATE OCTINOXATE 7.5 g
OCTISALATE OCTISALATE 5 g
OXYBENZONE OXYBENZONE 5 g
AVOBENZONE AVOBENZONE 3 g
OCTOCRYLENE Octocrylene 2.7 g

Inactive Ingredients

Ingredient Name Strength
water
cyclomethicone
C12-15 ALKYL BENZOATE
GLYCERIN
PEG-8/SMDI COPOLYMER
Propylene Glycol Dicaprylate/Dicaprate
LAURYL GLUCOSIDE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER
ALPHA-TOCOPHEROL ACETATE
PHENOXYETHANOL
.ALPHA.-BISABOLOL, (+/-)-
CHLORPHENESIN
XANTHAN GUM
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
EDETATE SODIUM
LAVANDULA ANGUSTIFOLIA WHOLE
BIOSACCHARIDE GUM-1
PELARGONIUM GRAVEOLENS FLOWER OIL
MANGANESE GLUCONATE
ROSMARINUS OFFICINALIS WHOLE
CUPRESSUS SEMPERVIRENS LEAF OIL
THYMUS VULGARIS WHOLE
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
OLEA EUROPAEA WHOLE
METHYLISOTHIAZOLINONE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51191-2046-2 150 in 1 BOTTLE, SPRAY

Marketing Information

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


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