ORASER DAILY HAND REPAIR BROAD-SPECTRUM SPF 20 SUNSCREEN- avobenzone, octinoxate, and oxybenzone lotion

ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen by

Drug Labeling and Warnings

ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Pak Lab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

ORASER DAILY HAND REPAIR BROAD-SPECTRUM SPF 20 SUNSCREEN 
avobenzone, octinoxate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Glycerin (UNII: PDC6A3C0OX)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Shea Butter (UNII: K49155WL9Y)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Styrene (UNII: 44LJ2U959V)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Pentylene Glycol (UNII: 50C1307PZG)
Polysorbate 60 (UNII: CAL22UVI4M)
Cetyl Alcohol (UNII: 936JST6JCN)
Stearic Acid (UNII: 4ELV7Z65AP)
Dimethicone (UNII: 92RU3N3Y1O)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ceteth-10 Phosphate (UNII: 4E05O5N49G)
Dihexadecyl Phosphate (UNII: 2V6E5WN99N)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Ethylhexyl Palmitate (UNII: 2865993309)
Aminomethylpropanol (UNII: LU49E6626Q)
Butylene Glycol (UNII: 3XUS85K0RA)
Panthenol (UNII: WV9CM0O67Z)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Sodium Lactate (UNII: TU7HW0W0QT)
Capryloyl Glycine (UNII: 8TY5YO42NJ)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Laminaria Ochroleuca (UNII: 4R2124HE76)
Sodium Ascorbate (UNII: S033EH8359)
Tocopherol (UNII: R0ZB2556P8)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2012

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Pak Lab		177711082	MANUFACTURE(42851-050)