SPF 25 UVA/UVB: Package Insert and Label Information

SPF 25 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 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 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,

alkyl (C12-15) benzoate, glyceryl stearate, ppg-12/smdi

copolymer, propylene glycol dicaprylate/dicaprate,

tromethamine, glycerin, cetyl alcohol, coco-glucoside,

peg-75 stearate, triticum vulgare (wheat) germ oil,

coconut alcohol, zea mays (corn) oil, dimethicone,

ceteth-20, steareth-20, citric acid, sclerotium gum,

xanthan gum, helianthus annuus (sunflower) seed oil,

tocopheryl acetate, vaccinium myrtillus (bilberry) fruit

extract, bisabolol, glycine soja (soybean) oil,

hydrolyzed sweet almond protein, saccharum

officinarum (sugar cane) extract/extrait de canne a

sucre, 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 limon fruit

extract / citrus medica limonum (lemon) fruit extract,

citrus aurantium dulcis (orange) fruit extract, hydrolyzed

soy protein, acer saccharum (sugar maple) extract,

mimosa tenuiflora bark extract, sodium hydroxide,

methylpropanediol, ethylhexylglycerin, chlorphenesin,

caprylhydroxamic acid, tetrasodium edta, sodium

dehydroacetate, sodium benzoate, linalool*, citronellol*,

geraniol*, limonene*.

*composants naturels d’huiles essentielles — natural com-

ponents of essentials oils

Etui SPF25 2025b
(click image for full-size original)

SPF 25 UVA/UVB
ensulizole, oxybenzone, avobenzone, octocrylene cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51191-3016
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 6 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
PEG-8/SMDI COPOLYMER
GLYCERYL MONOSTEARATE
PEG-75 STEARATE
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE
TROMETHAMINE
CETYL ALCOHOL
COCO GLUCOSIDE
.ALPHA.-BISABOLOL, (+/-)-
CHLORPHENESIN
XANTHAN GUM
EDETATE SODIUM
COCONUT ALCOHOL
CITRIC ACID MONOHYDRATE
.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
BETASIZOFIRAN
METHYLPROPANEDIOL
ETHYLHEXYLGLYCERIN
CAPRYLHYDROXAMIC ACID
PELARGONIUM GRAVEOLENS FLOWER OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51191-3016-1 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 (51191-3016), label (51191-3016)

Revised: 12/2019 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.