NDC | 68479-801-00, 68479-801-02, 68479-801-04, 68479-801-05, 68479-801-06 |
Set ID | f95050d9-a446-4191-a6cd-b996e1c72a56 |
Category | HUMAN OTC DRUG LABEL |
Packager | Dermalogica, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
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
-
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
-
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?
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
-
INGREDIENTS AND APPEARANCE
DYNAMIC SKIN RECOVERY SPF 50
avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-801 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 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) ROSEWOOD OIL (UNII: F2522O5L7B) Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC) SUNFLOWER OIL (UNII: 3W1JG795YI) LEMON OIL (UNII: I9GRO824LL) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LEMON PEEL (UNII: 72O054U628) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Squalane (UNII: GW89575KF9) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 1,2-Hexanediol (UNII: TR046Y3K1G) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Stearic Acid (UNII: 4ELV7Z65AP) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) Decyl Glucoside (UNII: Z17H97EA6Y) Polysorbate 80 (UNII: 6OZP39ZG8H) Urea (UNII: 8W8T17847W) Galactoarabinan (UNII: SL4SX1O487) Polysorbate 60 (UNII: CAL22UVI4M) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Ethylhexylglycerin (UNII: 147D247K3P) Phenoxyethanol (UNII: HIE492ZZ3T) Titanium Dioxide (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-801-02 1 in 1 CARTON 03/17/2014 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68479-801-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/17/2014 3 NDC:68479-801-00 2 mL in 1 POUCH; Type 0: Not a Combination Product 03/17/2014 4 NDC:68479-801-05 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/17/2014 5 NDC:68479-801-06 7 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/17/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/17/2014 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations COSWAY 620899877 MANUFACTURE(68479-801) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-801)