LIP TREATMENT DUO LIP SCRUB AND LIP BALM SUNSCREEN SPF 15- octinoxate, oxybenzone kit

LIP TREATMENT DUO LIP SCRUB AND LIP BALM SUNSCREEN SPF 15 by

Drug Labeling and Warnings

LIP TREATMENT DUO LIP SCRUB AND LIP BALM SUNSCREEN SPF 15 by is a Otc medication manufactured, distributed, or labeled by Trader Joe's Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 7.5%

Oxybenzone 3.0%

Purpose

Sunscreen

Use

 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 to only 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

apply liberally and evenly 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating reapply
at least every 2 hours Children under 6 months of age: Ask a doctor

Inactive ingredients

Diisostearyl Malate, Beeswax, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Euphorbia Cerifera (Candelilla) Wax, Citrus Sinensis (Sweet Orange) Peel Oil, Natural Flavor, Tocopherol (Vitamin E), Ascorbyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Punica Granatum (Pomegranate) Sterols, Olea Europaea (Olive) Oil Unsaponifiables, Butyrosperum Parkii (Shea) Butter, Macadamia Ternfolia Seed Oil, Persea Gratissima (Avocado) Oil, Phytosterols, Olea Europaea (Olive) Fruit Oil.

Other information 

Protect this product from excessive heat and direct sun may stain some fabrics

Questions or comments?

1- 626-599-3700 Monday – Friday 9 AM – 5 PM PST

SPL UNCLASSIFIED SECTION

Lip treatment duo

LIP SCRUB & LIP BALM SUNSCREEN SPF 15

with Jojoba Oil, Shea Butter and Macadamia Oil

Exfoliate & Hydrate

LIP SUGAR SCRUB

INGREDIENTS:Sugar (Sucrose), Coco-Caprylate/Caprate, Beeswax, Polyhydroxystearic Acid, Citrus Sinensis (Sweet Orange) Peel Oil, Euphorbia Cerifera (Candelilla) Wax, Natural Flavor, Tocopherol (Vitamin E), Ascorbyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Punica Granatum (Pomegranate) Sterols, Olea Europaea (Olive) Oil Unsaponifiables, Butyrospermum Parkii (Shea) Butter, Macadamia Ternifolia Seed Oil, Olea Europaea (Olive) Fruit Oil.

Directions for use: Sugar Scrub: gently massage sugar scrub on lips, then tissue off. Use up to 3 times per week. Lip Balm: For sunscreen use see Drug Facts Panel. For all other uses, smooth on balm anytime lips need moisture.

DIST. & SOLD EXCLUSIVELY BY: TRADER JOE’S,
800 S. SHAMROCK AVE., MONROVIA, CA 91016

NOT FOR INDIVIDUAL SALE.

Trader Joe's Lip Treatment Duo is exactly what you need for soft, smooth lips. A gentle sugar scrub helps buff away dry skin, while a replenishing lip balm, formulated with Jojoba Oil, Shea Butter and Macadamia Oil, works to revive and soften even the driest of lips.

Packaging

INGREDIENTS AND APPEARANCE

LIP TREATMENT DUO LIP SCRUB AND LIP BALM SUNSCREEN SPF 15 
octinoxate, oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71270-612

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71270-612-55	1 in 1 BOX; Type 0: Not a Combination Product	08/08/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	7 g
Part 2	1 TUBE	7 g

Part 1 of 2

LIP BALM SUNSCREEN SPF 15 
octinoxate, oxybenzone ointment

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CANDELILLA WAX (UNII: WL0328HX19)
ORANGE OIL (UNII: AKN3KSD11B)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
JOJOBA OIL (UNII: 724GKU717M)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
AVOCADO OIL (UNII: 6VNO72PFC1)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
OLIVE OIL (UNII: 6UYK2W1W1E)

Product Characteristics
Color	yellow (Yellowish)	Score
Shape		Size
Flavor	VANILLA, ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352

Part 2 of 2

LIP SCRUB 
other skin care preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SUCROSE (UNII: C151H8M554)
INGR	COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
INGR	YELLOW WAX (UNII: 2ZA36H0S2V)
INGR	POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	CANDELILLA WAX (UNII: WL0328HX19)
INGR	.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
INGR	ASCORBYL PALMITATE (UNII: QN83US2B0N)
INGR	JOJOBA OIL (UNII: 724GKU717M)
INGR	POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
INGR	OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	MACADAMIA OIL (UNII: 515610SU8C)
INGR	OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/08/2017

Labeler - Trader Joe's Company (006226666)