LIP RENEWAL SPF 50- avobenzone, homosalate, octinoxate, octisalate paste

Lip Renewal SPF 50 by

Drug Labeling and Warnings

Lip Renewal SPF 50 by is a Otc medication manufactured, distributed, or labeled by June Jacobs Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone...........................3.0%

Homosalate...........................10.0%

Octinoxate.............................7.5%

Octisalate..............................5.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

Warnings

For External use only

DO NOT USE

Do not use on

• damaged or broken skin

WHEN USING

When using this product

• Keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If product is swallowed, get madical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally and evenly every 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor
• Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use as sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun especially from 10am -2 pm.
• wear long sleeve shirt, pants hats and sunglasses

INACTIVE INGREDIENT

Inactive Ingredients

Microcrystalline Wax, Diisostearyl Malate, Glyceryl Diisostearate, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter, Dimethicone, Glycerin, Vitis Vinifera (Grape) Seed Oil, Flavor (Aroma), Triisostearin, Tocopherol, Squalane, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Allantoin, Water/ Aqua, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hyaluronic Acid, Phenoxyethanol, Limonene, Citral

OTHER SAFETY INFORMATION

Other Information

• Protect this product from excessive heat and direct sun.

QUESTIONS

Questions or comments?

Call toll free 1-866-JUNEJACOBS

• www.JUNEJACOBS.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIP RENEWAL SPF 50 
avobenzone, homosalate, octinoxate, octisalate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65278-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g  in 14 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.42 g  in 14 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1.4 g  in 14 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.7 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYALURONIC ACID (UNII: S270N0TRQY)
WATER (UNII: 059QF0KO0R)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
MENTHOL (UNII: L7T10EIP3A)
VANILLIN (UNII: CHI530446X)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
DIMETHICONE (UNII: 92RU3N3Y1O)
GRAPE SEED OIL (UNII: 930MLC8XGG)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
SPEARMINT OIL (UNII: C3M81465G5)
CARVONE, (+/-)- (UNII: 75GK9XIA8I)
TRIISOSTEARIN (UNII: 71503RH8KG)
TOCOPHEROL (UNII: R0ZB2556P8)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
GLYCERIN (UNII: PDC6A3C0OX)
CITRAL (UNII: T7EU0O9VPP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SHEA BUTTER (UNII: K49155WL9Y)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
ALLANTOIN (UNII: 344S277G0Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
JOJOBA OIL (UNII: 724GKU717M)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SQUALANE (UNII: GW89575KF9)
VITIS VINIFERA SEED (UNII: C34U15ICXA)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65278-105-01	14 g in 1 TUBE; Type 0: Not a Combination Product	12/09/2012
2	NDC: 65278-105-02	14 g in 1 CARTON; Type 0: Not a Combination Product	12/09/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/09/2012

Labeler - June Jacobs Labs, LLC (082439410)

Establishment
Name	Address	ID/FEI	Business Operations
June Jacobs Labs, LLC		122610681	manufacture(65278-105)