DYNAMIC SKIN RECOVERY SPF 50- avobenzone and octinoxate lotion

Dynamic Skin Recovery by

Drug Labeling and Warnings

Dynamic Skin Recovery by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., Paklab, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, Aniba Rosaeodora (Rosewood) Wood Oil, Rose Flower Oil, Pelargonium Graveolens Flower Oil, Helianthus Annuus (Sunflower) Seed Oil, Eugenia Caryophyllus (Clove) Leaf/ Flower Oil, Citrus Medica Limonum (Lemon) Peel Oil, Saccharomyces Cerevisiae Extract, Camellia Sinensis Leaf Extract, Citrus Medica Limonum (Lemon) Peel Extract, Algae Extract, Dipotassium Glycyrrhizate, Lecithin, Glucosamine HCL, Arginine/Lysine Polypeptide, Tocopheryl Acetate, Squalane, Sodium Hyaluronate, Polysilicone-11, Glycine Soja (Soybean) Protein, 1,2-Hexanediol, Caprylic/Capric Trilyceride, Cetearyl Alcohol, Stearic Acid, Ceteareth-20, Sodium Polyacrylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Acrylates Copolymer, Decyl Glucoside, Polysorbate 80, Urea, Galactoarabinan, Glyceryl Polyacrylate, Polysorbate 60, Aminomethyl Propanol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Titanium Dioxide (CI77891).

Questions or comments

Call toll free 1-800-831-5150 in the US.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

dynamic
skin
recovery

spf
50

broad
spectrum

UVA high protection

AGE smart®

1.7 US FL OZ
50 mL e

dermalogica®

INGREDIENTS AND APPEARANCE

DYNAMIC SKIN RECOVERY   SPF 50
avobenzone and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-318
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)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.S At 1%) (UNII: 86FQE96TZ4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Squalane (UNII: GW89575KF9)
Polysilicone-15 (UNII: F8DRP5BB29)
Egg Phospholipids (UNII: 1Z74184RGV)
Galactoarabinan (UNII: SL4SX1O487)
Stearic Acid (UNII: 4ELV7Z65AP)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Ethylhexylglycerin (UNII: 147D247K3P)
Aminomethylpropanol (UNII: LU49E6626Q)
Edetate Disodium (UNII: 7FLD91C86K)
Polysorbate 60 (UNII: CAL22UVI4M)
Rosewood Oil (UNII: F2522O5L7B)
Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Sunflower Oil (UNII: 3W1JG795YI)
1,2-Hexanediol (UNII: TR046Y3K1G)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Sodium Polyacrylate (8000 MW) (UNII: 285CYO341L)
Lemon Oil (UNII: I9GRO824LL)
Clove Leaf Oil (UNII: VCA5491KVF)
Urea (UNII: 8W8T17847W)
Glucosamine Hydrochloride (UNII: 750W5330FY)
Saccharomyces Lysate (UNII: R85W246Z1C)
Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO)
Decyl Glucoside (UNII: Z17H97EA6Y)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Lemon Peel (UNII: 72O054U628)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-318-02	1 in 1 CARTON
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68479-318-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 68479-318-00	2 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/09/2013

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Paklab		790530976	MANUFACTURE(68479-318)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-318)