RACHEL K MINERAL CC BLEMISH BALM

Dosage form: cream
Ingredients: TITANIUM DIOXIDE 2.4g in 40g, OCTINOXATE 2g in 40g, OCTISALATE 0.8g in 40g
Labeler: RACHEL K COSMETICS PTE. LTD.
NDC Code: 53241-010

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.

ACTIVE INGREDIENT

Active ingredients: TITANIUM DIOXIDE 6%, ETHYLHEXYL METHOXYCINNAMATE 5%, ETHYLHEXYL SALICYLATE 2%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Dimethicone, Cyclopentasiloxane, Mica, Dipropylene Glycol, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Vinyl Dimethicone/ Methicone Silsesquioxane Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, PEG-10 Dimethicone, PEG-9 PolydimethylSiloxyethyl Dimethicone, 4-Methylbenzylidene Camphor, Dimethicone/PEG-10/15 Crosspolymer, Benzophenone-3, Silica, Talc, Sorbitan Olivate, Sodium Chloride, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Silica dimethyl silylate, Sodium Citrate, Methylparaben, Centella Asiatica Extract, Tocopheryl Acetate, Propylparaben, Butylene Glycol, Sodium Hyaluronate, Arbutin, Adenosine, Human Oligopeptide-1, Ultramarines, Fragrance

PURPOSE

Purpose: Sunscreen

WARNINGS

PRECAUTION:
For external use only.
Do not swallow.
Keep out of reach of children.
Avoid contact with eyes.
Do not store it in extreme high or low temperatures

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

APPLICATION:
1. Apply the cream on your face in five dots to the forehead, nose, two cheeks and chin.
2. Blend the cream evenly throughout the whole face in a gentle patting motion.
3. Leave the cream in for 2-3 minutes until it disappears.
4. Cream will dry into a powdery matte finish and skin will appear dewy with a radiant glow.

DOSAGE AND ADMINISTRATION

APPLICATION:
1. Apply the cream on your face in five dots to the forehead, nose, two cheeks and chin.
2. Blend the cream evenly throughout the whole face in a gentle patting motion.
3. Leave the cream in for 2-3 minutes until it disappears.
4. Cream will dry into a powdery matte finish and skin will appear dewy with a radiant glow.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

RACHEL K MINERAL CC  BLEMISH BALM
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53241-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.4 g  in 40 g
OCTINOXATE (OCTINOXATE) OCTINOXATE2 g  in 40 g
OCTISALATE (OCTISALATE) OCTISALATE0.8 g  in 40 g
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
CYCLOMETHICONE 5 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:53241-010-0140 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/15/2012
Labeler - RACHEL K COSMETICS PTE. LTD. (595309583)
Registrant - RACHEL K COSMETICS PTE. LTD. (595309583)
Establishment
NameAddressID/FEIOperations
RACHEL K COSMETICS PTE. LTD.595309583manufacture(53241-010)

Revised: 09/2012
 
RACHEL K COSMETICS PTE. LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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