PRIME PRIMER HYDRATING BALM by F&CO Co., Ltd.

PRIME PRIMER HYDRATING BALM by

Drug Labeling and Warnings

PRIME PRIMER HYDRATING BALM by is a Otc medication manufactured, distributed, or labeled by F&CO Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRIME PRIMER HYDRATING BALM- titanium dioxide cream 
F&CO Co., 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.

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ACTIVE INGREDIENT

Active ingredient: Titanium Dioxide 0.1%

INACTIVE INGREDIENT

Inactive ingredients:
Cyclopentasiloxane, Methyl Trimenthicone, Neopentyl Glycol Diethylhexanoate, Methyl Methacrylate Crosspolymer, Dextrin Palmitate, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cyclohexasiloxane, Aluminum Starch Octenylsuccinate, Stearoyl Inulin, Microcrystalline Wax, Silica, Diisostearyl Malate, Butylparaben, Fragrance(Parfum), Water, Polyglyceryl-2 Triisostearate, Macadamia Integrifolia Seed Oil, Montmorillonite, Corylus Americana (Hazel) Seed Oil, Butylene Glycol, Blue 1 Lake (CI 42090), Yellow 5 Lake (CI 19140), Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Glyceryl Caprylate, Onsen-sui, Phenoxyethanol

PURPOSE

Purpose: Sunscreen

CAUTION

CAUTION:
If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

How to Use

How to Use: Smooth over bare skin, especially where pores and fine lines are visible, to mattify skin.

Dosage & Administration

Dosage & Administration:
Oil-free, mineral-based hydrating & mattifying balm that can be used under makeup to smooth away the look of pores & fine lines and minimize shine for even makeup application.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRIME PRIMER HYDRATING BALM 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 20 g

Inactive Ingredients
Ingredient Name	Strength
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-150-01	20 g in 1 CARTON; Type 0: Not a Combination Product	07/01/2014	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2014	11/01/2019

Labeler - F&CO Co., Ltd. (690166186)

Registrant - F&CO Co., Ltd. (690166186)

Establishment
Name	Address	ID/FEI	Business Operations
F&CO Co., Ltd.		690166186	manufacture(69106-150)

Revised: 1/2020

Document Id: 753839f8-3438-4838-8a02-801e581ff1f9

34390-5

Set id: 154e4f9e-fa35-4212-9ef4-a96b9d994df5

Version: 2

Effective Time: 20200109

 

F&CO Co., Ltd.