PEP START HYDRORUSH MOISTURIZER BROAD SPECTRUM SPF 20- avobenzone and octisalate cream 
CLINIQUE LABORATORIES 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.

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PEP START HYDRORUSH MOISTURIZER BROAD SPECTRUM SPF 20

Drug Facts

Active ingredients

Avobenzone 3.0%
Octisalate 5.0%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not 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

For sunscreen use:

Inactive ingredients

water\aqua\eau • butyloctyl salicylate • glycerin • polyester-8 • polysorbate 60 • dimethicone • butylene glycol • cetyl alcohol • sorbitan stearate • tridecyl stearate • pentylene glycol • sigesbeckia orientalis (st. paul's wort) extract • laminaria saccharina extract • plankton extract • arabidopsis thaliana extract • lactobacillus ferment • ergothioneine • palmitoyl tetrapeptide-7 • sea whip extract • hordeum vulgare (barley) extract\extrait d'orge • caffeine • algae extract • squalane • ethylhexylglycerin • trehalose • palmitoyl tripeptide-1 • triticum vulgare (wheat) germ extract • micrococcus lysate • tridecyl trimellitate • tocopheryl acetate • dipentaerythrityl hexacaprylate/hexacaprate • peg-100 stearate • acrylates/c10-30 alkyl acrylate crosspolymer • cetyl palmitate • sorbitan palmitate • sorbitan olivate • sodium benzoate • ethylene/va copolymer • dimethiconol • tetrahexyldecyl ascorbate • sodium hydroxide • sodium polyacrylate • polyethylene • lecithin • sodium hyaluronate • carbomer • polysorbate 20 • disodium edta • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • bht • chlorphenesin • phenoxyethanol [iln42436]

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

CLINIQUE
pep-start

hydrorush moisturizer
broad spectrum
SPF 20

NET WT. 1.7 OZ./50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
PEP START HYDRORUSH MOISTURIZER BROAD SPECTRUM SPF 20 
avobenzone and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
butyloctyl salicylate (UNII: 2EH13UN8D3)  
glycerin (UNII: PDC6A3C0OX)  
polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) (UNII: T9296U138P)  
polysorbate 60 (UNII: CAL22UVI4M)  
dimethicone (UNII: 92RU3N3Y1O)  
butylene glycol (UNII: 3XUS85K0RA)  
cetyl alcohol (UNII: 936JST6JCN)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
tridecyl stearate (UNII: A8OE252M6L)  
pentylene glycol (UNII: 50C1307PZG)  
saccharina latissima (UNII: 68CMP2MB55)  
arabidopsis thaliana (UNII: AI3L60HQ81)  
lactobacillus reuteri (UNII: 9913I24QEE)  
ergothioneine (UNII: BDZ3DQM98W)  
palmitoyl tetrapeptide-7 (UNII: Q41S464P1R)  
pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)  
barley (UNII: 5PWM7YLI7R)  
caffeine (UNII: 3G6A5W338E)  
squalane (UNII: GW89575KF9)  
ethylhexylglycerin (UNII: 147D247K3P)  
trehalose (UNII: B8WCK70T7I)  
palmitoyl tripeptide-1 (UNII: RV743D216M)  
wheat germ (UNII: YR3G369F5A)  
tridecyl trimellitate (UNII: FY36J270ES)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
peg-100 stearate (UNII: YD01N1999R)  
carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
cetyl palmitate (UNII: 5ZA2S6B08X)  
sorbitan monopalmitate (UNII: 77K6Z421KU)  
sorbitan olivate (UNII: MDL271E3GR)  
sodium benzoate (UNII: OJ245FE5EU)  
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
sodium hydroxide (UNII: 55X04QC32I)  
high density polyethylene (UNII: UG00KM4WR7)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
carboxypolymethylene (UNII: 0A5MM307FC)  
polysorbate 20 (UNII: 7T1F30V5YH)  
edetate disodium anhydrous (UNII: 8NLQ36F6MM)  
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
chlorphenesin (UNII: I670DAL4SZ)  
phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-054-011 in 1 CARTON09/01/2016
150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2016
Labeler - CLINIQUE LABORATORIES LLC (044475127)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(49527-054) , REPACK(49527-054)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(49527-054)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(49527-054)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(49527-054)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(49527-054)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(49527-054) , REPACK(49527-054)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(49527-054) , REPACK(49527-054)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(49527-054)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(49527-054)

Revised: 11/2019
Document Id: 578bfc71-3dae-4166-bd57-7d134d418796
Set id: e2769aff-b1be-45cd-a6ce-fa7faaa08716
Version: 3
Effective Time: 20191118
 
CLINIQUE LABORATORIES LLC