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NDC 10157-1119-05 Blistex Medicated Lip Balm 2; 6.6; 4.4 g/100g; g/100g; g/100g Details

Blistex Medicated Lip Balm 2; 6.6; 4.4 g/100g; g/100g; g/100g

Blistex Medicated Lip Balm is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc. The primary component is DIMETHICONE; OCTINOXATE; OCTISALATE.

Product Information

NDC	10157-1119
Product ID	10157-1119_ee878272-afcc-44fc-85d4-a4a450302f7c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Blistex Medicated Lip Balm
Proprietary Name Suffix	n/a
Non-Proprietary Name	DIMETHICONE, OCTINOXATE, and OCTISALATE
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	2; 6.6; 4.4
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	DIMETHICONE; OCTINOXATE; OCTISALATE
Labeler Name	Blistex Inc
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10157-1119-05 (10157111905)

Pricing Information	N/A
NDC Package Code	10157-1119-5
Billing NDC	10157111905
Package	5 CYLINDER in 1 CARTON (10157-1119-5) / 4.25 g in 1 CYLINDER
Marketing Start Date	2020-12-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8b4160ed-8889-4e3a-947f-a56c3324dbbe Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Dimethicone 2.0% (w/w)	Lip protectant
Octinoxate 6.6% (w/w)	Sunscreen
Octisalate 4.4% (w/w)	Sunscreen

Uses

temporarily protects and helps relieve chapped or cracked lips
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 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 the product in this container from excessive heat and direct sun

Inactive ingredients

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

Blistex®

LIP PROTECTANT/SUNSCREEN

MEDICATED

LIP BALM

Seals In Moisture

To Soothe & Prevent Dry Lips

Net Wt. 0.15 oz. (4.25 g)

SPF 15

Smooth

Easy-Gliding

Protection

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

INGREDIENTS AND APPEARANCE

BLISTEX MEDICATED LIP BALM

dimethicone, octinoxate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10157-1119
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.6 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
LANOLIN OIL (UNII: OVV5IIJ58F)
YELLOW WAX (UNII: 2ZA36H0S2V)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CETYL ALCOHOL (UNII: 936JST6JCN)
PARAFFIN (UNII: I9O0E3H2ZE)
COCOA BUTTER (UNII: 512OYT1CRR)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O)
METHYL SALICYLATE (UNII: LAV5U5022Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 6 (UNII: 481744AI4O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10157-1119-1	1 in 1 CARTON	01/15/2018
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC:10157-1119-3	3 in 1 CARTON	01/15/2018
2		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
3	NDC:10157-1119-4	4 in 1 CARTON	01/15/2018
3		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
4	NDC:10157-1119-5	5 in 1 CARTON	12/16/2020
4		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	01/15/2018

Labeler - Blistex Inc (005126354)

Name	Address	ID/FEI	Business Operations
Establishment
Blistex Inc		005126354	MANUFACTURE(10157-1119)

Revised: 12/2020

Document Id: ee878272-afcc-44fc-85d4-a4a450302f7c

Set id: 8b4160ed-8889-4e3a-947f-a56c3324dbbe

Version: 3

Effective Time: 20201216

Search by Drug Name or NDC

NDC 10157-1119-05 Blistex Medicated Lip Balm 2; 6.6; 4.4 g/100g; g/100g; g/100g Details

Blistex Medicated Lip Balm 2; 6.6; 4.4 g/100g; g/100g; g/100g

Product Information

Package

Package Images

NDC 10157-1119-05 (10157111905)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8b4160ed-8889-4e3a-947f-a56c3324dbbe Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Skin Cancer/Skin Aging Alert

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

INGREDIENTS AND APPEARANCE

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