SPF 50 UVA/UVB: Package Insert and Label Information

SPF 50 UVA/UVB- octocrylene, oxybenzone, avobenzone and ensulizole cream
MULTALER ET 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.

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 BENZOPHENONE-3

CONTAINS BENZOPHENONE-3

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,
GLYCERIN ,
PEG-100 STEARATE,
TROMETHAMINE,
MAGNESIUM ALUMINUM SILICATE,
PROPYLENE GLYCOL,
PRUNUS ARMENIACA (APRICOT) KERNEL OIL,
SORBITAN STEARATE,
CAPRYLYL GLYCOL,
BISABOLOL ,
DIMETHICONE,
CHLORPHENESIN,
XANTHAN GUM,
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,
TOCOPHERYL ACETATE ,
PANTHENOL,
CAPRYLHYDROXAMIC ACID,
CAMELLIA SINENSIS LEAF EXTRACT,
ISOHEXADECANE,
TETRASODIUM EDTA,
RETINYL PALMITATE,
DIPOTASSIUM GLYCYRRHIZATE,
MALTODEXTRIN,
POLYSORBATE 80,
ASPALATHUS LINEARIS LEAF EXTRACT ,
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,
PANTOLACTONE,
TOCOPHEROL.

Box SPF 50
(click image for full-size original)

SPF 50 UVA/UVB
ensulizole, oxybenzone, avobenzone, octocrylene cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51191-3015
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 8 g in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 5 g in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
ALKYL (C12-15) BENZOATE
GLYCERIN
PPG-12/SMDI COPOLYMER
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
.ALPHA.-BISABOLOL, (+/-)-
CHLORPHENESIN
XANTHAN GUM
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)
EDETATE SODIUM
MAGNESIUM ALUMINUM SILICATE
PROPYLENE GLYCOL
APRICOT KERNEL OIL
SORBITAN MONOSTEARATE
.ALPHA.-TOCOPHEROL ACETATE
PANTHENOL
ISOHEXADECANE
VITAMIN A PALMITATE
GREEN TEA LEAF
GLYCYRRHIZINATE DIPOTASSIUM
MALTODEXTRIN
POLYSORBATE 80
ASPALATHUS LINEARIS LEAF
CAPRYLHYDROXAMIC ACID
CAPRYLYL GLYCOL
SUNFLOWER OIL
DIMETHICONE
TROMETHAMINE
PANTOLACTONE, (+/-)-
TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51191-3015-1 50 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/15/2013
Labeler — MULTALER ET CIE S.A.S. (509613345)
Registrant — MULTALER ET CIE S.A.S. (509613345)
Establishment
Name Address ID/FEI Operations
MULTALER ET CIE S.A.S. 509613345 manufacture (51191-3015), label (51191-3015)

Revised: 05/2021 MULTALER ET CIE S.A.S.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.