PHOTO DYNAMIC THERAPY SPF 30- avobenzone, octinoxate, octisalate, and oxybenzone lotion

PHOTO DYNAMIC THERAPY SPF 30 by

Drug Labeling and Warnings

PHOTO DYNAMIC THERAPY SPF 30 by is a Otc medication manufactured, distributed, or labeled by G.S. COSMECEUTICAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
Avobenzone 3.0%	Sunscreen
Octinoxate 7.5%	Sunscreen
Octisalate 5.0%	Sunscreen
Oxybenzone 6.0%	Sunscreen

Use

Broad spectrum protection

Warnings

• For external use only.

• UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen.
• Do not get into eyes. Rinse with water to remove.

• Stop use and consult a doctor if skin rash occurs.

• Keep out of reach of children.

Directions

Apply daily. Do not seek additional sun exposure. Contains broad spectrum SPF 30. For best results, apply generously 15 minutes prior to sun exposure. Reapply every 2 hours while outdoors. For children under 6 months of age: consult a doctor. Store at room temperature 59-86°F / 15-30°C.

Other Ingredients

Aqua (Water), C12-15 Alkyl Benzoate, Yeast Amino Acids, Polysorbate 20, Glycerin, Butyloctyl Salicylate, Methyl Methacrylate / Glycol Dimethacrylate Crosspolymer, Stearic Acid, Glyceryl Stearate SE, Tricalcium Phosphate, Cyclohexasiloxane, Cyclopentasiloxane, Sorbitan Oleate, Lentinula Edodes (Shiitake Mushroom) Extract, Benzylidene Dimethoxydimethylindanone, Morinda Citrifolia Extract, Camellia Oleifera (Green Tea) Leaf Extract, Camellia Sinensis (White Tea) Leaf Extract, Punica Granatum (Pomegranate) Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Arnica Montana Flower Extract, Anacyclus Pyrethrum Root Extract, Sodium Hyaluronate, Ubiquinone, Tocopherol, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Carbomer, Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Disodium EDTA, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben

Questions or Comments?

ask@DERMAdoctor.com

www.DERMAdoctor.com®

PRINCIPAL DISPLAY PANEL - 30 ml Carton

PHOTO
DYNAMIC
therapy™

sunlight-activated
laser lotion with
spf 30

anti-aging

DERMAdoctor®

30 ml – 1 oz e

INGREDIENTS AND APPEARANCE

PHOTO DYNAMIC THERAPY SPF 30 
avobenzone, octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65113-2432
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
YEAST (UNII: 3NY3SM6B8U)
AMINO ACIDS (UNII: 0O72R8RF8A)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SHIITAKE MUSHROOM (UNII: 1A64QN2D2F)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POMEGRANATE (UNII: 56687D1Z4D)
CUCUMBER (UNII: YY7C30VXJT)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ANACYCLUS PYRETHRUM ROOT (UNII: X820IRW34J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Product Characteristics
Color	YELLOW (Off white to Light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65113-2432-1	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2010

Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE