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

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.

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CC Cream Broad Spectrum SPF 30

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).


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

Carton

Tube

CC CREAM BROAD SPECTRUM SPF 30  MERLE NORMAN
homosalate, octinoxate, oxybenzone, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.0 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-170-021 in 1 CARTON06/19/2014
1NDC:57627-170-0135 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/19/2014
Labeler - Merle Norman Cosmetics (008479388)
Registrant - Merle Norman Cosmetics (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics008479388manufacture(57627-170)

Revised: 10/2019
Document Id: ee643b8b-a0a6-4b70-a6d0-23750dc4ef7a
Set id: 93ebe819-6763-400c-8320-812276168b6c
Version: 6
Effective Time: 20191022
 
Merle Norman Cosmetics