Label: DAILY DEFENSE SPF 15- avobenzone, octinoxate, octisalate, and oxybenzone lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 68479-800-00, 68479-800-02 - 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 November 18, 2015
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
-
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 15 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.
-
Inactive ingredients
Water/Aqua/Eau, Butylene Glycol, Caprylic/Capric Triglyceride, Glyceryl Stearate, Cetearyl Phosphate, Glycerin, Stearic Acid, Polyglyceryl-2 Stearate, Dimethicone, Lactamide MEA, Pyrus Malus (Apple) Fruit Extract, Dimethyl Capramide, Mahonia Aquifolium Root Extract, Lavandula Angustifolia (Lavender) Extract, Hydrolyzed Opuntia Ficus Indica Flower Extract, Triticum Vulgare (Wheat) Germ Extract, Saccharomyces Cerevisiae Extract, Lavandula Spica (Lavender) Flower Oil, Lavandula Hybrida Oil, Eucalyptus Globulus Leaf Oil, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Palmitoyl Tripeptide-5, Sodium DNA, Tocopherol, Allantoin, Panthenol, Glycerin Crosspolymer, Ascorbyl Tetraisopalmitate, Carbomer, Polyquaternium-10, Cetyl Alcohol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Disodium EDTA, Citric Acid, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol.
- Other information
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton
-
INGREDIENTS AND APPEARANCE
DAILY DEFENSE SPF 15
avobenzone, octinoxate, octisalate, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-800 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 65 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 30 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 35 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Glyceryl Monostearate (UNII: 230OU9XXE4) Cetyl Phosphate (UNII: VT07D6X67O) Glycerin (UNII: PDC6A3C0OX) Stearic Acid (UNII: 4ELV7Z65AP) Dimethicone (UNII: 92RU3N3Y1O) N-Lactoyl Ethanolamine (UNII: 900T44YNC7) Apple (UNII: B423VGH5S9) Dimethyl Capramide (UNII: O29Y6X2JEZ) Mahonia Aquifolium Root (UNII: 746TB9VNDP) Lavandula Angustifolia Flowering Top (UNII: 9YT4B71U8P) Vitis Vinifera Seed (UNII: C34U15ICXA) Wheat Germ (UNII: YR3G369F5A) Saccharomyces Cerevisiae (UNII: 978D8U419H) Hyaluronate Sodium (UNII: YSE9PPT4TH) Phenoxyethanol (UNII: HIE492ZZ3T) Cetyl Alcohol (UNII: 936JST6JCN) Panthenol (UNII: WV9CM0O67Z) Lavender Oil (UNII: ZBP1YXW0H8) Lavandin Oil (UNII: 9RES347CKG) Eucalyptus Oil (UNII: 2R04ONI662) Ascorbyl Tetraisopalmitate (UNII: 47143LT58A) Tocopherol (UNII: R0ZB2556P8) Allantoin (UNII: 344S277G0Z) Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO) Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E) Sodium NA-22 (UNII: N2511Z637B) Edetate Disodium (UNII: 7FLD91C86K) Ethylhexylglycerin (UNII: 147D247K3P) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Polidronium Chloride (UNII: 6716Z5YR3G) Egg Phospholipids (UNII: 1Z74184RGV) Aminomethylpropanol (UNII: LU49E6626Q) Citric Acid Monohydrate (UNII: 2968PHW8QP) Xanthan Gum (UNII: TTV12P4NEE) Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO) Caprylyl Glycol (UNII: 00YIU5438U) Hexylene Glycol (UNII: KEH0A3F75J) Potassium Sorbate (UNII: 1VPU26JZZ4) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-800-02 1 in 1 CARTON 1 100 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68479-800-00 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 04/13/2012 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations Cosway 620899877 MANUFACTURE(68479-800) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-800)
