ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen description, usages, side effects, indications, overdosage, supplying and lots more!

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ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen

ZO Skin Health, Inc.

ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Octinoxate 7.5% Sunscreen
Oxybenzone 2.0% Sunscreen

ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.

Do not use on damaged skin.

When using this product keep out of eyes.

Rinse with water to remove.

Stop using this product if skin rash occurs.

Keep out of reach of childen. If swallowed get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor
  • 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

ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen Other information

  • Protect the product in this container from excessive heat and direct sunlight
  • You may report a serious adverse reaction event from using this product to ZO Skin Health, Inc. 1 Technology Drive, Irvine, CA 92618

Inactive ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, C12-15 Alkyl Benzoate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Pentylene Glycol, Polysorbate 60, Cetyl Alcohol, Stearic Acid, Dimethicone, Phenoxyethanol, Ceteth-10 Phosphate, Dicetyl Phosphate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Ethylhexyl Palmitate, Aminomethyl Propanol, Butylene Glycol, Fragrance (Parfum), Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium PCA, Sodium Lactate, Capryloyl Glycine, Dipotassium Glycyrrhizate, Laminaria Ochroleuca Extract, Sodium Ascorbate, Tocopherol, Undecylenoyl Glycine, Arginine, Aspartic Acid, Disodium EDTA, PCA, Retinol, Carbomer, Glycine, Silica Dimethyl Silylate, Alanine, Polysorbate 20, Serine, Valine, Isoleucine, Proline, Threonine, Diacetyl Boldine, Histidine, Phenylalanine, Sodium Hyaluronate, Ubiquinone, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7

DIST BY
ZO Skin Health, Inc.
Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

ZO® SKIN HEALTH

BY ZEIN OBAGI, MD

ORASER®

DAILY HAND REPAIR
BROAD-SPECTRUM SPF 20
SUNSCREEN

beverly hills

100 mL / 3.4 Fl. Oz.

ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen

ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen

Avobenzone, Octinoxate, and Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42851-050
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 30 mg
OCTINOXATE OCTINOXATE 75 mg
OXYBENZONE OXYBENZONE 20 mg

Inactive Ingredients

Ingredient Name Strength
water
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERIN
ALKYL (C12-15) BENZOATE
SHEA BUTTER
CETOSTEARYL ALCOHOL
STYRENE
BUTYLOCTYL SALICYLATE
PENTYLENE GLYCOL
POLYSORBATE 60
CETYL ALCOHOL
STEARIC ACID
DIMETHICONE
PHENOXYETHANOL
CETETH-10 PHOSPHATE
DIHEXADECYL PHOSPHATE
.ALPHA.-TOCOPHEROL ACETATE
TETRAHEXYLDECYL ASCORBATE
ETHYLHEXYL PALMITATE
Aminomethylpropanol
BUTYLENE GLYCOL
PANTHENOL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
SODIUM PYRROLIDONE CARBOXYLATE
sodium lactate
Capryloyl Glycine
GLYCYRRHIZINATE DIPOTASSIUM
LAMINARIA OCHROLEUCA
sodium ascorbate
Tocopherol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42851-050-10 100 in 1 TUBE
2 NDC:42851-050-04 40 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-01-01


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