SOLAR DEFENSE BOOSTER  SPF50- avobenzone and octinoxate lotion 
Dermalogica, Inc.

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.

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Solar Defense Booster
SPF50

Drug Facts

Active Ingredients

Avobenzone 3.0%, Octinoxate 7.5%

Purpose

Sunscreen

Uses

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

Inactive ingredients

Water/Aqua, Butylene Glycol, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, Polysorbate 80, Ammonium Acryloyldimethyltaurate/VP Copolymer, Dimethyl Capramide, Nylon-12, Centella Asiatica Extract, Echinacea Purpurea Extract, Magnesium Ascorbyl Phosphate, Melissa Officinalis Leaf Extract, Camellia Oleifera Leaf Extract, Citrus Medica Limonum (Lemon) Peel Extract, Vitis Vinifera (Grape) Seed Extract, Lavandula Angustifolia (Lavender) Oil, Lecithin, Tocopherol, Allantoin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ascorbyl Tetraisopalmitate, Cocamidopropyl PG-Dimonium Chloride Phosphate, Sorbitan Sesquicaprylate, Caprylic/Capric Triglyceride, Squalane, Carbomer, Sodium DNA, Polysorbate 60, Disodium EDTA, Sodium Benzoate, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol, Titanium Dioxide (CI 77891).

Other information

Questions or comments

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PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

solar
defense
booster

spf
50

broad
spectrum

DIN# 02382687

1.7 US Fl . Oz.
50 mL e

dermalogica®

Principal Display Panel - 50 mL Bottle Carton
SOLAR DEFENSE BOOSTER   SPF50
avobenzone and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
NYLON-12 (UNII: 446U8J075B)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
LEMON PEEL (UNII: 72O054U628)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALLANTOIN (UNII: 344S277G0Z)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SQUALANE (UNII: GW89575KF9)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
HERRING SPERM DNA (UNII: 51FI676N6F)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-000-021 in 1 CARTON
150 mL in 1 BOTTLE, PLASTIC
2NDC:68479-000-002 mL in 1 POUCH
3NDC:68479-000-04125 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/13/2012
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Gordon008328619MANUFACTURE(68479-000)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-000)

Revised: 12/2013
Document Id: 7d487462-89bc-4a73-989d-cad0eae0614f
Set id: 2c21121e-b94c-4555-b651-012aa552bfa9
Version: 1
Effective Time: 20131216
 
Dermalogica, Inc.