SPF 8 LIP MOISTURIZERS- zinc oxide kit

SPF 8 Lip Moisturizers by

SPF 8 Lip Moisturizers by is a Otc medication manufactured, distributed, or labeled by Juice Beauty. Drug facts, warnings, and ingredients follow.

SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredient

Zinc oxide 4%
Purpose

Sunscreen
Uses

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 generously before sun exposure and as needed. Children under 6 months of age, ask a doctor. Generously glide over lips and use often.
Other Information

Minimal sun protection product. Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.
Inactive Ingredients

Organic plant oils of helianthus annuus (organic sunflower seed oil)1, ricinus communis (organic castor seed oil)1, euphorbia cerifera (candelilla wax), theobroma cacao (organic cocoa seed butter)1, cocos nucifera (organic coconut oil)1, fragaria ananassa (organic strawberry flavor)1, aloe barbadensis (organic aloe oil)1, vaccinium corymbosum (organic blueberry flavor)1, tocopherol (Vitamin E). May contain titanium dioxide, mica, iron oxides.

1 certified organic ingredient

www.juicebeauty.com

juice BEAUTY
THE ORGANIC SOLUTION™

SPF 8 Lip Moisturizers
.15 oz / 4.25 g ea

SPF 8 LIP MOISTURIZERS
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55165-0201

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55165-0201-1	1 in 1 CARTON; Type 0: Not a Combination Product	10/10/2014

Part 1 of 3

SPF 8 LIP MOISTURIZER JOYFUL
zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Sunflower Oil (UNII: 3W1JG795YI)
Candelilla Wax (UNII: WL0328HX19)
COCOA BUTTER (UNII: 512OYT1CRR)
Coconut Oil (UNII: Q9L0O73W7L)
Castor Oil (UNII: D5340Y2I9G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
Mica (UNII: V8A1AW0880)
Titanium Dioxide (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/10/2014

Part 2 of 3

SPF 8 LIP MOISTURIZER NATURALLY CLEAR
zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	4 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/10/2014

Part 3 of 3

SPF 8 LIP MOISTURIZER PLAYFUL
zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Sunflower Oil (UNII: 3W1JG795YI)
Candelilla Wax (UNII: WL0328HX19)
COCOA BUTTER (UNII: 512OYT1CRR)
Coconut Oil (UNII: Q9L0O73W7L)
Castor Oil (UNII: D5340Y2I9G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
Mica (UNII: V8A1AW0880)
Titanium Dioxide (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/10/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/10/2014

Labeler - Juice Beauty (263151582)