YESTO POMEGRANATE LIP BUTTER WITH SPF 15- zinc oxide stick

YesTo Pomegranate Lip Butter with SPF 15 by

Drug Labeling and Warnings

YesTo Pomegranate Lip Butter with SPF 15 by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide (7.6%)

Purpose

Sunscreen

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 sun.

Warnings

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 Doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.  Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor.

Sun Protection Measure

Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeved shirts, pants, hats and sun-glasses. 

Inactive Ingredients

Beeswax, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Flavor, Glycine Soja (Soybean) Oil, Copernicia Cerifera (Carnauba) Wax, Jojoba Esters, Butyrospermum Parkii (Shea Butter)*, Ammonium Glycyrrhizate, Tocopherol (Vitamin E), Aloe Barbadensis Leaf Extract*, Limonene, Linalool. * Certified Organic Ingredient

Other Information

Protect this product from excessive heat and direct sun

Principal Display Panel

Image Components

Principal Display Panel

Image Components

INGREDIENTS AND APPEARANCE

YESTO POMEGRANATE LIP BUTTER WITH SPF 15 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	Zinc Oxide	7.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX (UNII: 7G1J5DA97F)
COCONUT OIL (UNII: Q9L0O73W7L)
OLIVE OIL (UNII: 6UYK2W1W1E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SOYBEAN OIL (UNII: 241ATL177A)
POMEGRANATE (UNII: 56687D1Z4D)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DECYL JOJOBATE (UNII: ZL61O8TFZU)
SHEA BUTTER (UNII: K49155WL9Y)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
CITRAL (UNII: T7EU0O9VPP)
EUGENOL (UNII: 3T8H1794QW)
GERANIOL (UNII: L837108USY)

Product Characteristics
Color		Score
Shape		Size
Flavor	POMEGRANATE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0307-1	4.2 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2013

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0307)