Label: SPF 50 UVA/UVB- ensulizole, oxybenzone, avobenzone, octocrylene cream
- NDC Code(s): 51191-3015-1
- Packager: MULTALER ET CIE S.A.S.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated May 31, 2021
If you are a consumer or patient please visit this version.
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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. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPF 50 UVA/UVB
ensulizole, oxybenzone, avobenzone, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51191-3015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 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) PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) EDETATE SODIUM (UNII: MP1J8420LU) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) APRICOT KERNEL OIL (UNII: 54JB35T06A) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PANTHENOL (UNII: WV9CM0O67Z) ISOHEXADECANE (UNII: 918X1OUF1E) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SUNFLOWER OIL (UNII: 3W1JG795YI) DIMETHICONE (UNII: 92RU3N3Y1O) TROMETHAMINE (UNII: 023C2WHX2V) PANTOLACTONE, (+/-)- (UNII: IID733HD2M) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51191-3015-1 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(51191-3015) , label(51191-3015)
