SPF 25 UVA/UVB- ensulizole, oxybenzone, avobenzone, octocrylene cream

SPF 25 UVA/UVB by

Drug Labeling and Warnings

SPF 25 UVA/UVB by is a Otc medication manufactured, distributed, or labeled by MULTALER ET CIE S.A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-75 STEARATE (UNII: OT38R0N74H)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
TROMETHAMINE (UNII: 023C2WHX2V)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCO GLUCOSIDE (UNII: ICS790225B)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE SODIUM (UNII: MP1J8420LU)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHEAT GERM OIL (UNII: 14C97E680P)
CORN OIL (UNII: 8470G57WFM)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
SUGARCANE (UNII: 81H2R5AOH3)
ACER SACCHARUM SAP (UNII: 75UOH57984)
BILBERRY (UNII: 9P2U39H18W)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SOY PROTEIN (UNII: R44IWB3RN5)
SOYBEAN OIL (UNII: 241ATL177A)
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
ALMOND (UNII: 3Z252A2K9G)
LEMON (UNII: 24RS0A988O)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)
CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)
THYME OIL (UNII: 2UK410MY6B)
ORANGE (UNII: 5EVU04N5QU)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51191-3016-1	50 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2013

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	Business Operations
MULTALER ET CIE S.A.S.		509613345	manufacture(51191-3016) , label(51191-3016)