SOLAR DEFENSE BOOSTER SPF50- avobenzone and octinoxate lotion

Solar Defense Booster by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 3.0%, Octinoxate 7.5%

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
• Children under 6 months: ask a doctor

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

• 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 - 50 mL Bottle Carton

solar
defense
booster

spf
50

broad
spectrum

DIN# 02382687

1.7 US Fl . Oz.
50 mL e

dermalogica®

INGREDIENTS AND APPEARANCE

SOLAR DEFENSE BOOSTER   SPF50
avobenzone and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-000
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	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-000-02	1 in 1 CARTON
1		50 mL in 1 BOTTLE, PLASTIC
2	NDC: 68479-000-00	2 mL in 1 POUCH
3	NDC: 68479-000-04	125 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/13/2012

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Gordon		008328619	MANUFACTURE(68479-000)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-000)