PURELIGHT SPF50- avobenzone and octinoxate lotion

PureLight by

Drug Labeling and Warnings

PureLight by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., THIBIANT, 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 30 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.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Butylene Glycol, Glycerin, C12-15 Alkyl Benzoate, Polysorbate 80, Dimethyl Capramide, Sodium Hyaluronate Crosspolymer, Cananga Odorata Flower Oil, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Oil, Lavendula Spica (Lavender) Flower Oil, Laminaria Ochroleuca Extract, Palmaria Palmata Extract, Oligopeptide-34, Dipotassium Glycyrrhizate, Lactobacillus/Pumpkin Fruit Ferment Filtrate, Niacinamide, Zinc Glycinate, Polysorbate 60, Ammonium Acryloyldimethyltaurate/VP Copolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Butylene Glycol Behenate, Glyceryl Polyacrylate, Disodium EDTA, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

pure
light

spf
50
broad
spectrum

UVA high protection

PowerBright TRx™

1.7 US FL OZ / 50 mL e

dermalogica®

INGREDIENTS AND APPEARANCE

PURELIGHT   SPF50
avobenzone and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-213
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	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)
Butylene Glycol (UNII: 3XUS85K0RA)
Glycerin (UNII: PDC6A3C0OX)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Dimethyl Capramide (UNII: O29Y6X2JEZ)
Cananga Oil (UNII: 8YOY78GNNX)
Eucalyptus Oil (UNII: 2R04ONI662)
Lavandin Oil (UNII: 9RES347CKG)
Lavender Oil (UNII: ZBP1YXW0H8)
Laminaria Ochroleuca (UNII: 4R2124HE76)
Dulse (UNII: 7832HOY4ZQ)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Niacinamide (UNII: 25X51I8RD4)
Zinc Glycinate (UNII: 681VJX72FE)
Polysorbate 60 (UNII: CAL22UVI4M)
Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)
Isohexadecane (UNII: 918X1OUF1E)
Butylene Glycol Behenate (UNII: X0IW5BP6ZL)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Hydroxide (UNII: 55X04QC32I)
Ethylhexylglycerin (UNII: 147D247K3P)
Phenoxyethanol (UNII: HIE492ZZ3T)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-213-02	1 in 1 CARTON	02/18/2014
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-213-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	02/18/2014
3	NDC: 68479-213-01	10 mL in 1 TUBE; Type 0: Not a Combination Product	02/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/18/2014

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
THIBIANT		083913913	MANUFACTURE(68479-213)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-213)