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

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ORASER ® DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen
National Drug Code: 42851-050

Drug Facts

Active ingredientsPurpose
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

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.

Principal Display Panel - 100 mL Tube Carton
ORASER DAILY HAND REPAIR BROAD-SPECTRUM SPF 20 SUNSCREEN 
avobenzone, octinoxate, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-050-10100 mL in 1 TUBE
2NDC:42851-050-0440 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/01/201208/01/2016
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
Pak Lab177711082manufacture(42851-050)

Revised: 2/2023
Document Id: f49da51b-3f68-7a63-e053-2a95a90a24e2
Set id: 7db91231-bb5d-464c-9920-fc9470ec31b3
Version: 2
Effective Time: 20230213
 
ZO Skin Health, Inc.