JULEP LIP SHADE SHEER LIP BUTTER RAISIN SPF 30- octinoxate, oxybenzone, octisalate, avobenzone, octocrylene lipstick 
Julep Nail Parlor

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.

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Julep Lip Shade Sheer Lip Butter SPF 30 Raisin

Active Ingredients

Octinoxate - 6.75%

Oxybenzone - 5.4%

Octisalate - 4.5%

Avobenzone - 3.0%

Octocrylene - 2.0%

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and earl skin aging.  This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

​For External Use Only

Do no 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 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 of age; ask a doctor.

Other Information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Bis-Diglyceryl Polyacyladipate-2, Brassica Oleracea Italica (Broccoli) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric/Myristic/Stearic Triglyceride, Caryodendron Orinocense Seed Oil, Castor (Ricinus Communis) Seed Oil, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax,
Diisostearyl Malate, Ethyl Vanillin, Ethylcellulose, Euphorbia Cerifera (Candelilla) Wax, Flavor, Hydrogenated Dilinoleyl Alcohol, Isostearyl Alcohol,
Microcrystalline Wax, Octyldodecanol, Pentaerythrityl Tetraisostearate, Phenoxyethanol, Polyethylene, Ribes Nigrum (Black Currant) Seed Oil,
Tocopheryl Acetate, Tribehenin, Vitis Vinifera (Grape) Seed Oil, May Contain (+/-): Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), (CI 77491), (CI 77499), Red 7 Lake (CI 15850), Yellow 5 Lake (CI 19140), Mica (CI 77019), Red 6 Lake (CI 15850), D&C Red 6 (CI 15850), Blue 1 Lake (CI 42090), Red 27 lake (CI 45410).

Sheer Lipp

JULEP LIP SHADE SHEER LIP BUTTER RAISIN  SPF 30
octinoxate, oxybenzone, octisalate, avobenzone, octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76280-309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.75 g  in 100.00 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.4 g  in 100.00 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100.00 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100.00 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.0 g  in 100.00 g
Inactive Ingredients
Ingredient NameStrength
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
BRASSICA OLERACEA VAR. ITALICA WHOLE (UNII: DW4954EP53)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
CANDELILLA WAX (UNII: WL0328HX19)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
BLACK CURRANT (UNII: 9755T40D11)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MICA (UNII: V8A1AW0880)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76280-309-021 in 1 CARTON07/01/2016
1NDC:76280-309-013.4 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/01/201612/31/2016
Labeler - Julep Nail Parlor (023413483)

Revised: 3/2017
Document Id: fed8b102-225b-4198-87a8-91767deaf647
Set id: 3e2e6ef9-b83b-4aa6-9021-66b8206ad5ff
Version: 3
Effective Time: 20170327
 
Julep Nail Parlor