LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35: Package Insert and Label Information

LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, titanium dioxide and zinc oxide liquid
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
Octinoxate 7.40% Sunscreen
Octisalate 4.00% Sunscreen
Oxybenzone 2.50% Sunscreen
Titanium Dioxide 2.20% Sunscreen
Zinc Oxide 2.00% 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 • TRIOCTYLDODECYL CITRATE • METHYL TRIMETHICONE • DIMETHICONE • OCTYLDODECYL STEAROYL STEARATE • BUTYLENE GLYCOL • PHENYL TRIMETHICONE • PENTYLENE GLYCOL • GLYCERYL STEARATE • BEHENYL ALCOHOL • POLYMETHYLSILSESQUIOXANE • PEG-40 STEARATE • POLYGLYCERYL-10 PENTASTEARATE • ACETYL GLUCOSAMINE • TOCOPHERYL ACETATE • SODIUM HYALURONATE • LECITHIN • SQUALANE • SIGESBECKIA ORIENTALIS (ST. PAUL’S WORT) EXTRACT • HORDEUM VULGARE (BARLEY) EXTRACT • TRITICUM VULGARE (WHEAT) GERM EXTRACT • LAMINARIA SACCHARINA EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • PYRUS MALUS (APPLE) FRUIT EXTRACT • SCUTELLARIA BAICALENSIS ROOT EXTRACT • CAFFEINE • CHOLESTEROL • GLYCERIN • SODIUM PCA • POLYGLYCERYL-6 POLYRICINOLEATE • ORYZANOL • TREHALOSE • OCTYLDODECYL NEOPENTANOATE • ACETYL HEXAPEPTIDE-8 • PROPYLENE GLYCOL STEARATE • PROPYLENE GLYCOL LAURATE • ISOPROPYL MYRISTATE • ALUMINA • SODIUM STEAROYL LACTYLATE • XANTHAN GUM • SUCROSE • UREA • POLYMETHYL METHACRYLATE • DISODIUM EDTA • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER • SILICA • ISOPROPYL TITANIUM TRIISOSTEARATE • SORBITAN LAURATE • POLYSORBATE 20 • POLYQUATERNIUM-51 • STEARIC ACID • LINOLEIC ACID • GLYCYRRHETINIC ACID • PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE • PHENOXYETHANOL • CHLORPHENESIN • SODIUM DEHYDROACETATE • [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) • TITANIUM DIOXIDE (CI 77891)] <ILN37913>

Other information

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

PRINCIPAL DISPLAY PANEL — 50 ml Carton

LAB
SERIES
SKINCARE FOR MEN

BB TINTED
MOISTURIZER
BROAD
SPECTRUM
SPF 35

oil free

TREAT

1.7 FL. OZ./OZ. LIQ. 50 ml e

Principal Display Panel -- 50 ml Carton
(click image for full-size original)
LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35
octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42472-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 74 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 40 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 25 mg in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 22 mg in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TRIOCTYLDODECYL CITRATE
METHYL TRIMETHICONE
DIMETHICONE
OCTYLDODECYL STEAROYL STEARATE
BUTYLENE GLYCOL
PHENYL TRIMETHICONE
PENTYLENE GLYCOL
GLYCERYL MONOSTEARATE
DOCOSANOL
PEG-40 STEARATE
N-ACETYLGLUCOSAMINE
.ALPHA.-TOCOPHEROL ACETATE
HYALURONATE SODIUM
SQUALANE
WHEAT GERM
SACCHARINA LATISSIMA
CUCUMBER
APPLE
SCUTELLARIA BAICALENSIS ROOT
CAFFEINE
CHOLESTEROL
GLYCERIN
SODIUM PYRROLIDONE CARBOXYLATE
ORYZANOL
TREHALOSE
OCTYLDODECYL NEOPENTANOATE
ACETYL HEXAPEPTIDE-8
PROPYLENE GLYCOL MONOSTEARATE
PROPYLENE GLYCOL MONOLAURATE
ISOPROPYL MYRISTATE
ALUMINUM OXIDE
SODIUM STEAROYL LACTYLATE
XANTHAN GUM
SUCROSE
UREA
EDETATE DISODIUM
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
SILICON DIOXIDE
ISOPROPYL TITANIUM TRIISOSTEARATE
SORBITAN MONOLAURATE
POLYSORBATE 20
STEARIC ACID
LINOLEIC ACID
ENOXOLONE
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
PHENOXYETHANOL
CHLORPHENESIN
SODIUM DEHYDROACETATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42472-002-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (42472-002-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/24/2011
Labeler — Aramis Inc. (042918826)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE (42472-002)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER N.V 370151326 MANUFACTURE (42472-002)
Establishment
Name Address ID/FEI Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE (42472-002)
Establishment
Name Address ID/FEI Operations
PADC 1 949264774 REPACK (42472-002), RELABEL (42472-002)
Establishment
Name Address ID/FEI Operations
WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE (42472-002)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COMPANY, THE 828534516 REPACK (42472-002), RELABEL (42472-002)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE (42472-002)
Establishment
Name Address ID/FEI Operations
NORTHTEC INC 943871157 REPACK (42472-002), RELABEL (42472-002)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE (42472-002)

Revised: 11/2020 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.