PRIME PRIMER BB by F&CO Co., Ltd.

PRIME PRIMER BB by

Drug Labeling and Warnings

PRIME PRIMER BB 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 BB NUDE- titanium dioxide, octinoxate, zinc oxide 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 ingredients: Titanium Dioxide 9.69%, Ethylhexyl Methoxycinnamate 5.0%, Zinc Oxide 2.94%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Cyclopentasiloxane, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Dimethicone, PEG-10 Dimethicone, Triethylhexanoin, Methyl Methacrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Sodium Chloride, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Aluminum Hydroxide, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Stearic Acid, Chlorphenesin, Methylparaben, Fragrance(Parfum), Iron Oxides (CI 77491), Triethoxycaprylylsilane, Propylparaben, Iron Oxides (CI 77499), Disodium EDTA, Butylene Glycol, Coral Powder, Silica, Portulaca Oleracea Extract, Fomes Officinalis (Mushroom) Extract, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Corrageenan, PEG-40 Hydrogenated Castor Oil, Hydrogenated Lecithin, Propylene Glycol, Algin, Glycine Soja (Soybean) Oil, Potassium Sorbate, Lecithin, Sodium Benzoate, Sodium Dehydroacetate, Citric Acid, Alcohol Denat., Sorbic Acid, Polysorbate 60, rh-Oligopeptide-1

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: Moisturize your skin and use fingertips to apply a pearl-size amount evenly.

Dosage & Administration

Dosage & Administration:
Prime Primer BB Cream visibly reduces discoloration and darkening with Sebum Control & Primer benefits that finishes lightweight and sleek.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRIME PRIMER BB  NUDE
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.90 mg  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.5 mg  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.88 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-190-01	30 mL 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(69106-190)

Revised: 1/2020

Document Id: 9b9bbbc6-6f8b-4ed1-af5c-c62170d8e7fc

34390-5

Set id: 227a7152-cfef-44dc-9884-1e551d7d12aa

Version: 2

Effective Time: 20200108

 

F&CO Co., Ltd.