CC CREAM BROAD SPECTRUM SPF 30 MERLE NORMAN- homosalate, octinoxate, oxybenzone, titanium dioxide cream

CC Cream Broad Spectrum SPF 30 by

Drug Labeling and Warnings

CC Cream Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active (medicinal) Ingredients (w/w)      Purpose
Homosalate 7.0%                               Sunscreen

Octinoxate 2.5%                                 Sunscreen

Oxybenzone 2.0%                              Sunscreen

Titanium Dioxide 4.1%                        Sunscreen

Uses

helps prevent sunburn

if used as directed withother sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Utilisations

aide à prévenir les coups de soleil

amoindrit le risque de cancer et de vieillissement prématuré de la peau causés par le soleil lorsque utilisé comme indiqué en conjonction avec d’autres  mesures de protection solaire (voir Mode d’emploi).

Keep out of reach of children

Stop use and ask a doctor if rash occurs. En cas de rougeurs cessez l'utilisationet consultez un medecin.

Warnings

For external use only

Do not use on damaged or broken skin When using this product

keep out of eyes. Rinse with water to remove.

If swallowed, get medical help or contact a Poison Control Center right away.

Avertissements

À usage externe seulement

Ne pas utilisersur une peau abîmée ou des plaies ouvertes

Faites attention à vos yeux

lorsque vous utilisez ce produit. Nettoyez avec de l’eau.

Ne pas laisser à la portée des enfants.

Si vous avalez ce produit, consultez un médecin ou contactez immédiatement un centre antipoison.

Drug Facts

Directions

For sunscreen use:

apply liberally and evenly 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

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 Spectrum SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m.-2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor

Mode d’emploi

Pour vous protéger de soleil:

appliquez généreusement et uniformément 15 minutes avant de vous mettre au soleil

utilisez un écran solaire résistant a l’eau si vous nagez ou transpirez

réappliquez au moins toutes les 2 heures

Mesures de protection contre le soleil.

L’exposition au soleil accroît le risque de cancer et de vieillissement prématuré de la peau. Pour amoindrir ce risque, utilisez

régulièrement un écran solaire à ample protection FPS 15 ou plus et observez d’autres mesures de protection contre le soleil

telles que:

limiter le temps d’exposition au soleil, surtout entre 10 heures et 14 heures

porter des chemises à manches longues, des pantalons, des chapeaux et des lunettes de soleil

pour les enfants de moins de 6 mois: Consulter un médecin

Inactive (non-medicinal)ingredients

Water (Aqua), Methy l Trimethicone, Propylene Glycol Dicaprylate/Dicaprate, Isododecane, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, HDI/Trimethylol Hexyllactone Crosspolymer, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Dimethicone, Magnesium Sulfate, Lauroyl Lysine, Tocopheryl Acetate, CitrullusLanatus (Watermelon) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Pyrus Malus(Apple) Fruit Extract, Hippophae Rhamnoides Fruit Extract,Portulaca Oleracea Extract,Palmitoyl Tripeptide-38, Sodium PCA, Sodium Lactate,Sodium Ascorbyl Glucoside, Sodium Myristoyl Glutamate,Maltodextrin, Sorbitan Sesquioleate, Aluminum Hydroxide (CI 77002), Stearic Acid, Cyclopentasiloxane, Caprylyl Glycol, Zinc Oxide (CI 77947), Butylene Glycol, Ethylhexylglycerin, Acrylates/ Dimethicone Copolymer, Dimethicone/PEG-10/15 Crosspolymer, Triethoxycaprylylsilane, Sorbic Acid, Trisodium EDTA, Hydroxypropyl Cyclodextrin, Potassium Sorbate, Sodium Benzoate, Disteardimonium Hectorite, Propylene Carbonate, Phenoxyethanol, Methylparaben, Propylparaben, Ethylparaben,

May Contain/ Peut Contenir (+/-), Iron Oxides (CI 77489, CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

PRINCIPAL DISPLAY PANEL

CC Cream Broad Spectrum SPF 30

Complexion Corrector

Creme Correctrice de Teint

Large Spectre FPS 30

Merle Norman

35 g Net Wt. 1.25 oz

INGREDIENTS AND APPEARANCE

CC CREAM BROAD SPECTRUM SPF 30  MERLE NORMAN
homosalate, octinoxate, oxybenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.0 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
ISODODECANE (UNII: A8289P68Y2)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
LAUROYL LYSINE (UNII: 113171Q70B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATERMELON (UNII: 231473QB6R)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
APPLE (UNII: B423VGH5S9)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
PURSLANE (UNII: M6S840WXG5)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ALUMINUM HYDRIDE (UNII: KZJ3T010RQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ZINC OXIDE (UNII: SOI2LOH54Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SORBIC ACID (UNII: X045WJ989B)
EDETATE TRISODIUM (UNII: 420IP921MB)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
FERROUS OXIDE (UNII: G7036X8B5H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-170-02	1 in 1 CARTON	06/19/2014
1	NDC: 57627-170-01	35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/19/2014

Labeler - Merle Norman Cosmetics (008479388)

Registrant - Merle Norman Cosmetics (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics		008479388	manufacture(57627-170)