RACHEL K MINERAL CC PRESSED: Package Insert and Label Information

RACHEL K MINERAL CC PRESSED- titanium dioxide powder
RACHEL K COSMETICS PTE. LTD.

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 ingredient: TITANIUM DIOXIDE 7%

INACTIVE INGREDIENT

Inactive ingredients:
MICA, KAOLIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, ZINC STEARATE, SILICA, IRON OXIDE YELLOW, IRON OXIDE RED, DIISOSTEARYL MALATE, HYDROGENATED LECITHIN, IRON OXIDE BLACK, DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, BUTYLPARABEN, ALLANTOIN, TOCOPHERYL ACETATE, BUTYROSPERMUM PARKII (SHEA BUTTER)

PURPOSE

Purpose: Sunscreen

WARNINGS

Caution:
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

HOW TO USE:
Apply with Powder Brush or included sponge applicator.
Can be used all over face, or just on oily spots.

DOSAGE AND ADMINISTRATION

HOW TO USE:
Apply with Powder Brush or included sponge applicator.
Can be used all over face, or just on oily spots.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

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RACHEL K MINERAL CC PRESSED
titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53241-020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.84 g in 12 g
Inactive Ingredients
Ingredient Name Strength
KAOLIN
MEDIUM-CHAIN TRIGLYCERIDES
ZINC STEARATE
DIMETHICONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53241-020-01 12 g in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/15/2012
Labeler — RACHEL K COSMETICS PTE. LTD. (595309583)
Registrant — RACHEL K COSMETICS PTE. LTD. (595309583)
Establishment
Name Address ID/FEI Operations
RACHEL K COSMETICS PTE. LTD. 595309583 manufacture (53241-020)

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

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