PREP SPF 15 LIP GLOSS- zinc oxide sunscreen gel 
PREP Cosmetics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

PREP SPF 15 Lip Gloss

Active Ingredient

Zinc Oxide 11%

Purpose

Sunscreen

Uses

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

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:

Other Information

Protect this product from excessive heat and direct sun

Questions?

Call toll-free 1-800-401-6031

www.prepyourskin.com

Inactive Ingredients

Back carton labelCastor 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

Carton label

PREP SPF 15 LIP GLOSS 
zinc oxide sunscreen gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70231-0012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE110 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70231-0012-71 in 1 CARTON01/11/2015
17 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/11/2015
Labeler - PREP Cosmetics LLC (053793815)
Registrant - Richard Hamer Associates LLC (067731889)
Establishment
NameAddressID/FEIBusiness Operations
Taka USA Inc. dba Cosmetic Innovations802860515manufacture(70231-0012) , pack(70231-0012)

Revised: 7/2018
Document Id: 724d0889-5b86-3125-e053-2a91aa0a92c1
Set id: 237fad3c-532b-3a1f-e054-00144ff8d46c
Version: 3
Effective Time: 20180731
 
PREP Cosmetics LLC