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

PEP START HYDRORUSH MOISTURIZER BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

PEP START HYDRORUSH MOISTURIZER BROAD SPECTRUM SPF 20 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES INC., ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistance sunscreen if swimming or sweating
• 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 of age: ask a doctor

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

INGREDIENTS AND APPEARANCE

PEP START HYDRORUSH MOISTURIZER BROAD SPECTRUM SPF 20 
avobenzone and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-054-01	1 in 1 CARTON	09/01/2016
1		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2016

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-054) , REPACK(49527-054)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-054)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-054)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-054)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-054)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-054) , REPACK(49527-054)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-054) , REPACK(49527-054)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-054)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-054)