AGE REVISION  SPF50- avobenzone and octinoxate lotion 
Dermalogica, 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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AGE Revision
SPF50

Drug Facts

Active ingredients

Avobenzone (3.0%)

Octinoxate (7.5%)

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), helps decrease 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 30 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 help decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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-sleeve shirts, pants, hats and sunglasses.
  • Do not use on infants under 6 months old.

Other information

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

Water/Aqua/Eau, Butylene Glycol, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Glycerin, Dimethicone, Dimethyl Capramide, Palmitoyl Tripeptide-5, Saccharomyces Cerevisiae Extract, Camellia Sinensis Leaf Extract, Algae Extract, Dipotassium Glycyrrhizate, Glucosamine HCL, Squalane, Sodium Hyaluronate, Glycine Soja (Soybean) Protein, 1,2-Hexanediol, Sodium Polyacrylate, Polysorbate 80, Cetearyl Alcohol, Polysilicone-11, Lecithin, Stearic Acid, Ceteareth-20, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Decyl Glucoside, Urea, Galactoarabinan, Glyceryl Polyacrylate, Polysorbate 60, Sodium Acrylates Copolymer, Aminomethyl Propanol, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin.

Questions or comments?

Call toll free 1-800-954-3223 in the US.

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

Age Revision
SPF 50

peptides +
white tea

UVA high protection

2.0 US FL OZ / 60 mL e

dermalogica MD®

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton
AGE REVISION   SPF50
avobenzone and octinoxate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-006
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
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Glycerin (UNII: PDC6A3C0OX)  
Dimethicone (UNII: 92RU3N3Y1O)  
Dimethyl Capramide (UNII: O29Y6X2JEZ)  
Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO)  
Saccharomyces Cerevisiae (UNII: 978D8U419H)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
Glucosamine Hydrochloride (UNII: 750W5330FY)  
Squalane (UNII: GW89575KF9)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Soy Protein (UNII: R44IWB3RN5)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Sodium Polyacrylate (8000 MW) (UNII: 285CYO341L)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Egg Phospholipids (UNII: 1Z74184RGV)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
Decyl Glucoside (UNII: Z17H97EA6Y)  
Urea (UNII: 8W8T17847W)  
Galactoarabinan (UNII: SL4SX1O487)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Aminomethylpropanol (UNII: LU49E6626Q)  
Edetate Disodium (UNII: 7FLD91C86K)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68479-006-01 1 in 1 CARTON 11/25/2014 10/08/2015
1 60 mL in 1 TUBE; Type 0: Not a Combination Product
2 NDC:68479-006-00 2 mL in 1 POUCH; Type 0: Not a Combination Product 11/25/2014 10/08/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 11/25/2014 10/08/2015
Labeler - Dermalogica, Inc. (177698560)
Establishment
Name Address ID/FEI Business Operations
PakLab 790530976 MANUFACTURE(68479-006)
Establishment
Name Address ID/FEI Business Operations
Diamond Wipes 161104729 MANUFACTURE(68479-006)

Revised: 12/2017
Dermalogica, Inc.