DERMA BRILLIANCE SUNSCREEN SPF 30- octinoxate, oxybenzone, octisalate, avobenzone and octocrylene cream

Derma Brilliance Sunscreen SPF 30 by

Drug Labeling and Warnings

Derma Brilliance Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Allure Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Octinaxate - 7.5%

Oxybenzone - 6.0%

Octisalate - 5.0%

Avobenzone - 2.0%

Octocrylene - 1.5%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses:

• This product is suited for broad spectrum UV protection.
  

WARNINGS

Warnings:

• For external use only.
  

WHEN USING

• Keep out of eyes.
• If, contacts occurs rinse with water.

STOP USE

Discontinue use if irritation or redness occurs.

ASK DOCTOR

Consult a doctor if sever irritation occurs.

DOSAGE & ADMINISTRATION

Directions:

• Apply using fingertips 20-30 minutes before exposure to the sun.
• Gently massage into face and neck.
• Reapply as needed.

INACTIVE INGREDIENT

Water, Alkyl(C12-15) Benzoate, Butylene Glycol, Octyldodecyl Neopentanoate, Hyaluronate Sodium, Kiwi Fruit, Medium chain Triglycerides, Green Tea Leaf, Teprenone, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Cyclomethicone 5, Cyclomethicone 6, Algae Extract, Artemisia Vulgaris Root, Centella Asiatica, Echinacea Purpurea, Lauryl Methacrylate / Glycol Dimethacrylate, Crosspolymer, Carbomer, Yeast Polysaccharides, Triethanolamine,Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene Glycol 400, Tocopherol, Ascorbyl  Palmitate, Ascorbic Acid, Citric Acid Monohydrate, Sorbitan Mono Oleate, Polysorbate 20, Palmitoyl Pentapeptide-4, Darutoside, Glycerin, Polygonum Aviculare Top, Arctostaphylos UVA-URSI Leaf, Mitracarpus Scaber Extract, Plankton Extract, Egg Phospholipids, Micrococcus Lysate, Arabidopsis Thaliana, Ubidecarenone, Edetate Disodium, Aloe Vera Leaf.

PRINCIPAL DISPLAY PANEL

Distributed by:

ICTV, 150 Stewart Parkway,

Greensboro, GA 30642 USA 77 Humberline Drive, Toronto,

Ont, Canada M9W0B6.

INGREDIENTS AND APPEARANCE

DERMA BRILLIANCE SUNSCREEN SPF 30 
octinoxate, oxybenzone, octisalate, avobenzone and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
KIWI FRUIT (UNII: 71ES77LGJC)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TEPRENONE (UNII: S8S8451A4O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
ECHINACEA PURPUREA (UNII: QI7G114Y98)
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
UBIDECARENONE (UNII: EJ27X76M46)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Trolamine (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4073-1	28.3 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/17/2015

Labeler - Allure Labs, Inc (926831603)