OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SPF30- julep time machine 
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 Time Machine Kit

Active Ingredients

Avobenzone 3.0%

Homosalate 5.0%

Octisalate 5.0%

Octocrylene 2.7%

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 the sun

Warnings

For external use only

Do not use

on damaged or broken skin

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
  • reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.
  • 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: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments?

Call toll free 1-877-585-3707

Inactive Ingredients

ALOE BARBADENSIS (ALOE LEAF JUICE), ALOE BARBADENSIS LEAF EXTRACT, AMINOMETHYL PROPANOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CEATEARYL ALCOHOL, CHLORPHENESIN,  CITRUS SINENSIS (BLOOD ORANGE) FRUIT EXTRACT, COCO CAPRYLATE/CAPRATE, DECYL GLUCOSIDE, DEXTRIN, DIMETHICONE, DISODIUM EDTA, ETHYLHEXYL STEARATE, FRAGRANCE/PARFUM, GLYCERIN, GLYCERYL STEARATE, HYDROLYZED HIBISCUS ESCULENTUS EXTRACT, ISODODECANE, PEG-100 STEARATE, PENTYLENE GLYCOL, PHENOXYETHANOL, POLYSILICONE-II, POLYURETHANE-34, SODIUM CITRATE, SODIUM POLYACRYLATE, TAPIOCA STARCH POLYMETHYLSILSESQUIOXANE, TOCOPHERYL ACETATE, TRIDECETH 6, WATER/EAU, XANTHAN GUM

Time Machine Kit

OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE  SPF30
julep time machine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76280-232
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76280-232-011 in 1 KIT; Type 0: Not a Combination Product09/10/2013
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 JAR 74 mL
Part 21 TUBE 89 mL
Part 1 of 2
JULEP FACIAL FOR HANDS GLYCOLIC PEEL-OFF MASK 
other manicuring preparations
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRALCOHOL (UNII: 3K9958V90M)  
INGRPOLYVINYL ALCOHOL (UNII: 532B59J990)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRGLYCOLIC ACID (UNII: 0WT12SX38S)  
INGRPEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
INGRPHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRSODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRXYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
INGRANHYDROXYLITOL (UNII: 8XWR7NN42F)  
INGRXYLITOL (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
174 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic09/10/2013
Part 2 of 2
OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE  SPF30
julep solace oil-free lotion
Product Information
Item Code (Source)NDC:76280-233
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ABELMOSCHUS ESCULENTUS SEED (UNII: 1GJ68JL4J5)  
ISODODECANE (UNII: A8289P68Y2)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76280-233-0189 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/10/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/10/201312/31/2019
Labeler - Julep Nail Parlor (023413483)

Revised: 12/2019
Document Id: 8139669b-a3d3-4883-a4dc-31e5a58ba5f3
Set id: 929c6742-107b-4026-a635-d82fe8ba4749
Version: 18
Effective Time: 20191216
 
Julep Nail Parlor