ROSEHIP AND LEMONGRASS LIP SPF 15- zinc oxide stick

Rosehip and Lemongrass Lip SPF 15 by

Drug Labeling and Warnings

Rosehip and Lemongrass Lip SPF 15 by is a Otc medication manufactured, distributed, or labeled by Eminence Organic Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Zinc Oxide 3.5%

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 a doctor if

• rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hou
• Use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly
  use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. – 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses
• 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

Olive Oil, Beeswax, Calendula, Comfrey, Lavender, Plantain, Yarrow, Rosehip Oil, Lemongrass Oil, Tangerine Oil, Lemon Oil, Vitamin E.

Lemongrass Lip Balm US 0.14 oz

INGREDIENTS AND APPEARANCE

ROSEHIP AND LEMONGRASS LIP SPF 15 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15751-1321
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
COMFREY (UNII: D05HXK6R3G)
PLANTAGO MAJOR (UNII: W2469WNO6U)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
MANDARIN OIL (UNII: NJO720F72R)
LEMON OIL (UNII: I9GRO824LL)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15751-1321-1	1 in 1 BOX	04/27/2016
1		4 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	04/27/2016

Labeler - Eminence Organic Skin Care (205753317)