2-POWER FABRIC SPF 25- octinoxate cream

2-Power Fabric SPF 25 by

Drug Labeling and Warnings

2-Power Fabric SPF 25 by is a Otc medication manufactured, distributed, or labeled by BPS 60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Octinoxate 6.7%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Flammable until dry.Do not use near fire, flame, or heat.

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

For sunscreen use:

●  apply liberally 15 minutes before sun exposure

●  reapply at least every 2 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 decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

cyclohexasiloxane, water, dimethicone, vinyl dimethicone/methicone silsesquioxane crosspolymer, propanediol, alcohol denat., butylene glycol, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethiocone, synthetic fluorphlogopite, tocopherol, phenoxyethanol, magnesium sulfate, PEG/PPG-18 dimethicone, polyglyceryl-4 isostearate, dimethicone/vinyl dimethicone crosspolymer, limonene, benzyl salicylate, benzyl alcohol, linalool, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, isobutane, acrylonitrile/methylmethacrylate/vinylidene chloride copolymer, disodium stearoyl glutamate, BHT, butylphenyl methylpropional, aluminum hydroxide, hexyl cinnamal, fragrance; may contain: iron oxides, titanium dioxide

Questions or comments?

CONTACT: GIORGIO ARMANI PARFUMS

LUXURY PRODUCTS LLC

10 HUDSON YARDS, NEW YORK, NY 10001

Package Labeling:

INGREDIENTS AND APPEARANCE

2-POWER FABRIC SPF 25 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70581-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PROPANEDIOL (UNII: 5965N8W85T)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
ISOBUTANE (UNII: BXR49TP611)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70581-011-00	1 in 1 BOX	12/25/2017
1		5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/25/2017

Labeler - BPS 60 (272259304)