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LAB SERIES SKINCARE FOR MEN

ARAMIS INC.

LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

LAB SERIES SKINCARE FOR MEN 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)]

LAB SERIES SKINCARE FOR MEN 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

LAB SERIES SKINCARE FOR MEN

LAB SERIES SKINCARE FOR MEN

OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42472-002
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.4 mL
OCTISALATE OCTISALATE 4 mL
OXYBENZONE OXYBENZONE 2.5 mL
titanium dioxide 2.2 mL
Zinc Oxide Zinc oxide 2 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 thallus
CUCUMBER
APPLE
SCUTELLARIA BAICALENSIS ROOT
CAFFEINE
CHOLESTEROL
GLYCERIN
SODIUM PYRROLIDONE CARBOXYLATE
GAMMA ORYZANOL
TREHALOSE
OCTYLDODECYL NEOPENTANOATE
ACETYL HEXAPEPTIDE-8
propylene glycol stearate
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 Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE
2 NDC:42472-002-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-04-24


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