LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15: Package Insert and Label Information

LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15- avobenzone, octinoxate and octisalate 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 Ingredient Purpose
Avobenzone 2.00% Sunscreen
Octinoxate 7.50% Sunscreen
Octisalate 3.00% 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 • BUTYLENE GLYCOL • SILICA • HYDROGENATED POLYISOBUTENE • NEOPENTYL GLYCOL DIETHYLHEXANOATE • CYCLOPENTASILOXANE • PENTYLENE GLYCOL • HYDROGENATED LECITHIN • ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE • SACCHAROMYCES LYSATE EXTRACT • ACETYL CARNITINE HCL • BETULA ALBA (BIRCH) BARK EXTRACT • PHYTOSPHINGOSINE • CREATINE • OCTYLDODECYL NEOPENTANOATE • COFFEA ROBUSTA SEED EXTRACT • ASTROCARYUM MURUMURU SEED BUTTER • ASCORBYL TOCOPHERYL MALEATE • ACETYL GLUCOSAMINE • LINOLEIC ACID • SODIUM HYALURONATE • TOCOPHERYL ACETATE • CETEARYL ALCOHOL • POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE • ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER • PHOSPHOLIPIDS • ETHYLHEXYLGLYCERIN • ISOHEXADECANE • CHOLESTEROL • NEOPENTYL GLYCOL DIISOSTEARATE • ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER • CAPRYLIC/CAPRIC TRIGLYCERIDE • GLYCERIN • LECITHIN • BEHENYL ALCOHOL • ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT • CHAMOMILLA RECUTITA (MATRICARIA) • ETHYLHEXYL STEARATE • CARBOMER • ETHYLHEXYL PALMITATE • PROPYLENE GLYCOL DICAPRATE • CYCLODEXTRIN • NORDIHYDROGUAIARETIC ACID • SODIUM DNA • LINOLENIC ACID • TRIETHANOLAMINE • SODIUM HYDROXIDE • POLYSORBATE 80 • HEXYLENE GLYCOL • DISODIUM EDTA • POTASSIUM SORBATE • SODIUM DEHYDROACETATE • CHLORPHENESIN • PHENOXYETHANOL • SORBIC ACID <ILN37073>

Other information

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

PRINCIPAL DISPLAY PANEL — 100 ml Tube Carton

LAB
SERIES
SKINCARE FOR MEN

DAILY MOISTURE
DEFENSE LOTION
BROAD SPECTRUM
SPF 15

fragrance free

TREAT

3.4 FL. OZ./OZ. LIQ.
100 ml e

Principal Display Panel -- 100 ml Tube Carton
(click image for full-size original)
LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15
avobenzone, octinoxate, and octisalate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42472-887
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.0212 g in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.0795 g in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 0.0318 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BUTYLENE GLYCOL
SILICON DIOXIDE
NEOPENTYL GLYCOL DIETHYLHEXANOATE
CYCLOMETHICONE 5
PENTYLENE GLYCOL
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE
SACCHAROMYCES LYSATE
ACETYLCARNITINE HYDROCHLORIDE
BETULA PUBESCENS BARK
PHYTOSPHINGOSINE
CREATINE
OCTYLDODECYL NEOPENTANOATE
ROBUSTA COFFEE BEAN
ASTROCARYUM MURUMURU SEED BUTTER
ASCORBYL TOCOPHERYL MALEATE
N-ACETYLGLUCOSAMINE
LINOLEIC ACID
HYALURONATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE
CETOSTEARYL ALCOHOL
ETHYLHEXYLGLYCERIN
ISOHEXADECANE
CHOLESTEROL
NEOPENTYL GLYCOL DIISOSTEARATE
GLYCERIN
DOCOSANOL
ROSEMARY
MATRICARIA CHAMOMILLA
ETHYLHEXYL STEARATE
ETHYLHEXYL PALMITATE
PROPYLENE GLYCOL DICAPRATE
MASOPROCOL
LINOLENIC ACID
TROLAMINE
SODIUM HYDROXIDE
POLYSORBATE 80
HEXYLENE GLYCOL
EDETATE DISODIUM
POTASSIUM SORBATE
SODIUM DEHYDROACETATE
CHLORPHENESIN
PHENOXYETHANOL
SORBIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42472-887-01 1 TUBE in 1 CARTON contains a TUBE
1 100 mL in 1 TUBE This package is contained within the CARTON (42472-887-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 01/01/2005
Labeler — ARAMIS INC. (042918826)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COMPANY, THE 828534516 RELABEL (42472-887), REPACK (42472-887)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE (42472-887)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE (42472-887)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER N.V. 370151326 MANUFACTURE (42472-887)
Establishment
Name Address ID/FEI Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE (42472-887)
Establishment
Name Address ID/FEI Operations
NORTHTEC INC 943871157 RELABEL (42472-887), REPACK (42472-887)
Establishment
Name Address ID/FEI Operations
PADC 1 949264774 RELABEL (42472-887), REPACK (42472-887)
Establishment
Name Address ID/FEI Operations
WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE (42472-887)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE (42472-887)

Revised: 12/2018 ARAMIS INC.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.