OTC Medication Information: LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35

LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35- avobenzone, homosalate, octisalate and oxybenzone lotion
Aramis Inc.

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.

Drug Facts

Active Ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Homosalate 5.0%	Sunscreen
Octisalate 4.5%	Sunscreen
Octocrylene 3.3%	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

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
• Reapply at least every two hours
• Use a water resistant 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 ∙ NYLON-12 ∙ OCTYLDODECYL NEOPENTANOATE ∙ BEHENYL ALCOHOL ∙ DIMETHICONE ∙ GLYCERIN ∙ MYRISTYL MYRISTATE ∙ CETYL ESTERS ∙ POLYETHYLENE ∙ BUTYLENE GLYCOL ∙ GLYCERYL STEARATE ∙ PEG-100 STEARATE ∙ PEG-6 ∙ AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER ∙ SIGESBECKIA ORIENTALIS (ST. PAUL’S WORT) EXTRACT ∙ THERMUS THERMOPHILLUS FERMENT ∙ SQUALANE ∙ ANASTATICA HIEROCHUNTICA (ROSE OF JERICHO) EXTRACT ∙ TRITICUM VULGARE (WHEAT) GERM EXTRACT ∙ HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D’ORGE ∙ BETULA ALBA (BIRCH) BARK EXTRACT ∙ LAMINARIA SACCHARINA EXTRACT ∙ SALICORNIA HERBACEA EXTRACT ∙ SACCHAROMYCES LYSATE EXTRACT ∙ ACETYL HEXAPEPTIDE-8 ∙ BIOSACCHARIDE GUM-4 ∙ CAFFEINE ∙ DIPOTASSIUM GLYCYRRHIZATE ∙ CHOLESTEROL ∙ SODIUM PCA ∙ SUCROSE ∙ LINOLEIC ACID ∙ TREHALOSE ∙ ALGAE EXTRACT ∙ TRISILOXANE ∙ SODIUM HYALURONATE ∙ POLYQUATERNIUM-51 ∙ LACTOBACILLUS FERMENT ∙ DI-PPG-2 MYRETH-10 ADIPATE ∙ STEARETH-21 ∙ TOCOPHERYL ACETATE∙ MYRISTYL LAURATE ∙ FRAGRANCE (PARFUM) ∙ CAPRYLYL GLYCOL ∙ MYRISTYL ALCOHOL ∙ UREA ∙ HEXYLENE GLYCOL ∙ SODIUM DEHYDROACETATE ∙ DISODIUM EDTA ∙ BHT ∙ PHENOXYETHANOL <ILN43958>

Other information

• Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL — 100 ml Tube Carton

SERIES
ALL-IN-ONE

DEFENSE LOTION
BROAD SPECTRUM
SPF 35

3.4 FL. OZ.
100 ml e

LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35 avobenzone, homosalate, octisalate, and oxybenzone lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42472-010 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 0.03 g in 1 mL HOMOSALATE (HOMOSALATE) HOMOSALATE 0.05 g in 1 mL OCTISALATE (OCTISALATE) OCTISALATE 0.045 g in 1 mL OXYBENZONE (OXYBENZONE) OXYBENZONE 0.033 g in 1 mL

Inactive Ingredients Ingredient Name Strength WATER BUTYLOCTYL SALICYLATE NYLON-12 OCTYLDODECYL NEOPENTANOATE DOCOSANOL DIMETHICONE GLYCERIN MYRISTYL MYRISTATE CETYL ESTERS WAX HIGH DENSITY POLYETHYLENE BUTYLENE GLYCOL GLYCERYL MONOSTEARATE PEG-100 STEARATE POLYETHYLENE GLYCOL 300 AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER THERMUS THERMOPHILUS LYSATE SQUALANE SELAGINELLA LEPIDOPHYLLA WHOLE WHEAT BARLEY ACETYL HEXAPEPTIDE-8 BIOSACCHARIDE GUM-4 CAFFEINE GLYCYRRHIZINATE DIPOTASSIUM CHOLESTEROL SODIUM PYRROLIDONE CARBOXYLATE SUCROSE LINOLEIC ACID TREHALOSE TRISILOXANE HYALURONATE SODIUM LIMOSILACTOBACILLUS REUTERI DI-PPG-2 MYRETH-10 ADIPATE STEARETH-21 MYRISTYL LAURATE CAPRYLYL GLYCOL MYRISTYL ALCOHOL UREA HEXYLENE GLYCOL SODIUM DEHYDROACETATE EDETATE DISODIUM ANHYDROUS BUTYLATED HYDROXYTOLUENE PHENOXYETHANOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42472-010-01 1 TUBE in 1 CARTON contains a TUBE 1 100 mL in 1 TUBE This package is contained within the CARTON (42472-010-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/01/2016

Labeler — Aramis Inc. (042918826)

Registrant — Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Operations
The Estee Lauder Inc		802599436	manufacture (42472-010), pack (42472-010), label (42472-010)

Revised: 05/2023 Aramis Inc.