Label: DYNAMIC SKIN RECOVERY SPF 50- avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68479-801-00, 68479-801-02, 68479-801-04, 68479-801-05, view more68479-801-06 - Packager: Dermalogica, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 21, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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Directions
- Apply liberally 30 minutes before sun exposure
- Reapply at least every two hours
- Use a water-resistant sunscreen if swimming or sweating
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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:
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- limit time in the sun, especially from 10 a.m. – 2 p.m.
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- wear long-sleeve shirts, pants, hats and sunglasses
- Do not use on infants under 6 months old.
- Other information
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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
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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)
