COVERGIRL TRUBLEND BASE BUSINESS EVERYDAY DEFENSE PRIMER SPF 20- ensulizole liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)
Available from:
NOXELL CORPORATION
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen helps prevent sunburn on damaged or broken skin. if rash occurs.
Authorization status:
OTC monograph not final
Authorization number:
22700-157-01

COVERGIRL TRUBLEND BASE BUSINESS EVERYDAY DEFENSE PRIMER SPF 20-

ensulizole liquid

NOXELL CORPORATION

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.

----------

Covergirl Everyday Defense Skin Primer SPF 20

Active ingredient

Ensulizole 3%

Purpos e

Sunscreen

Us es

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin

aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

children under 6 months of age: Ask a doctor

Other information

protect this product from excessive heat and direct sun

Aqua/Water/Eau, Cyclopentasiloxane, Talc, Propylene Glycol, Dimethicone, Aluminum Starch

Octenylsuccinate, PEG/PPG-18/18 Dimethicone, Sodium Chloride, PVP, Phenoxyethanol, Sodium

Hydroxide, Ethylene/Methacrylate Copolymer, Synthetic Beeswax, Trihydroxystearin, Methicone, 1,2-

Hexanediol, Caprylyl Glycol, Silica, Sodium Benzoate, Synthetic Wax, Polyglyceryl-4 Isostearate,

Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Isopropyl Titanium Triisostearate, Ethylene

Brassylate, Polyethylene.

Ques tions ?

1-800-426-8374

COVERGIRL

TRUBLEND

BASE BUSINESS

EVERYDAY

DEFENSE

SKIN PRIMER +

ENSULIZOLE SUNSCREEN

SPF 20

30 mL (1 FL OZ)

COVERGIRL TRUBLEND BASE BUSINESS EVERYDAY DEFENSE PRIMER SPF

20

ensulizole liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:2270 0 -157

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ENSULIZO LE (UNII: 9 YQ9 DI1W42) (ENSULIZOLE - UNII:9 YQ9 DI1W42)

ENSULIZOLE

3 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

ETHYLENE BRASSYLATE (UNII: 9 A8 7HC7ROD)

TALC (UNII: 7SEV7J4R1U)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

ALUMINUM STARCH O CTENYLSUCCINATE (UNII: I9 PJ0 O6 29 4)

NOXELL CORPORATION

HEXYL LAURATE (UNII: 4CG9 F9 W0 1Q)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

TRIHYDRO XYSTEARIN (UNII: 0 6 YD78 9 6 S3)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:2270 0 -157-0 1

30 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/28 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/28 /20 19

Labeler -

NOXELL CORPORAT ION (003082997)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NOXELL CORPORATION

0 0 30 8 29 9 7

ma nufa c ture (2270 0 -157)

Revised: 2/2020

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