PREP SPF 15 LIP GLOSS- zinc oxide sunscreen gel

PREP SPF 15 Lip Gloss by

Drug Labeling and Warnings

PREP SPF 15 Lip Gloss by is a Otc medication manufactured, distributed, or labeled by PREP Cosmetics LLC, Richard Hamer Associates LLC, Taka USA Inc. dba Cosmetic Innovations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 11%

Purpose

Sunscreen

Uses

• helps prevent sunburn

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.

Stop Use

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 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 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 am- 2 pm
• wear long-sleeved shirts, pants, hats. and sunglasses

Other Information

Protect this product from excessive heat and direct sun

Questions?

Call toll-free 1-800-401-6031

www.prepyourskin.com

Inactive Ingredients

Castor Oil, Coconut Oil, Diisostearyl Malate, Ethylhexylglycerin, Ferric Oxide Red, Isostearic Acid, Jojoba Oil, Potassium Sorbate, Propanediol, Spearmint Oil, Succinic Acid, Tocopherol, Triethoxycaprylylsilane, Yellow Wax

Carton Label

INGREDIENTS AND APPEARANCE

PREP SPF 15 LIP GLOSS 
zinc oxide sunscreen gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70231-0012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	110 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
YELLOW WAX (UNII: 2ZA36H0S2V)
CASTOR OIL (UNII: D5340Y2I9G)
ISOSTEARIC ACID (UNII: X33R8U0062)
SUCCINIC ACID (UNII: AB6MNQ6J6L)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SPEARMINT OIL (UNII: C3M81465G5)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70231-0012-7	1 in 1 CARTON	01/11/2015
1		7 mL 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 final	part352	01/11/2015

Labeler - PREP Cosmetics LLC (053793815)

Registrant - Richard Hamer Associates LLC (067731889)

Establishment
Name	Address	ID/FEI	Business Operations
Taka USA Inc. dba Cosmetic Innovations		802860515	manufacture(70231-0012) , pack(70231-0012)