DAILY DEFENSE SPF 15- avobenzone, octinoxate, octisalate, and oxybenzone lotion

Daily Defense by

Drug Labeling and Warnings

Daily Defense by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., Cosway, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone (3.0%), Octinoxate (6.5%), Octisalate (3.0%), Oxybenzone (3.5%).

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 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

• Protect this product from excessive heat and direct sun

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

daily
defense

spf
15
broad
spectrum

dermalogica®

3.4 US FL OZ
100 mL e

INGREDIENTS AND APPEARANCE

DAILY DEFENSE   SPF 15
avobenzone, octinoxate, octisalate, and oxybenzone lotion

Product 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)