RACHEL K MINERAL CC PRESSED- titanium dioxide powder

RACHEL K MINERAL CC PRESSED by

Drug Labeling and Warnings

RACHEL K MINERAL CC PRESSED by is a Otc medication manufactured, distributed, or labeled by RACHEL K COSMETICS PTE. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.84 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ZINC STEARATE (UNII: H92E6QA4FV)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53241-020-01	12 g in 1 CARTON

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	Business Operations
RACHEL K COSMETICS PTE. LTD.		595309583	manufacture(53241-020)