OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SPF30- julep solace oil-free sunscreen broad spectrum lotion 
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.

----------

Julep Solace SPF 30

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

SolaceUC

OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE  SPF30
julep solace oil-free sunscreen broad spectrum lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76280-231
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 89 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 89 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 89 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 89 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:76280-231-021 in 1 CARTON10/01/2013
1NDC:76280-231-0189 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 finalpart35210/01/201312/31/2019
Labeler - Julep Nail Parlor (023413483)

Revised: 12/2019
Document Id: d135005a-16d7-48c8-a8fb-c4124ff3adbb
Set id: 97628e66-1550-43b9-ba1c-c2202049e8f5
Version: 16
Effective Time: 20191216
 
Julep Nail Parlor