LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35: Package Insert and Label Information

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 — 50 ml Tube Carton

LAB
SERIES
SKINCARE FOR MEN

DAY RESCUE
DEFENSE LOTION
BROAD SPECTRUM
SPF 35

TREAT

1.7 FL. OZ.
50 ml e

PRINCIPAL DISPLAY PANEL -- 50 ml Tube Carton
(click image for full-size original)
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
PALC 078364654 pack (42472-010), label (42472-010)
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Ltd. 204132062 pack (42472-010), label (42472-010)
Establishment
Name Address ID/FEI Operations
Northtec LLC 943871157 pack (42472-010), label (42472-010)
Establishment
Name Address ID/FEI Operations
PADC 1 949264774 pack (42472-010), label (42472-010)
Establishment
Name Address ID/FEI Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture (42472-010), pack (42472-010), label (42472-010)
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Ltd. 202952982 manufacture (42472-010), pack (42472-010), label (42472-010)
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 manufacture (42472-010), pack (42472-010), label (42472-010)
Establishment
Name Address ID/FEI Operations
Estee Lauder N.V. 370151326 manufacture (42472-010), pack (42472-010), label (42472-010)

Revised: 08/2022 Aramis Inc.

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