Drug Facts
Active ingredients Purpose
Ensulizole 3% {
Oxybenzone 5% { Sunscreen
Avobenzone 3% {
Octocrylene 6% {
Spf 25 Uva/uvb
FDA Label NDC 51191-3016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Multaler Et Cie S.a.s. for the product Spf 25 Uva/uvb (NDC 51191-3016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, description, warnings and precautions, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
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
Warnings And Precautions
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 Ingredient
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
* Please review the disclaimer below.
