SKIN SO SOFT FIRM AND RESTORE NECK AND CHEST TREATMENT- octinoxate, oxybenzone, octisalate, avobenzone cream

Skin So Soft Firm and Restore by

Drug Labeling and Warnings

Skin So Soft Firm and Restore by is a Otc medication manufactured, distributed, or labeled by New Avon LLC, Fareva Morton Grove Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Octinoxate 7.5%......................
Oxybenzone 3.0%...................
Octisalate 3.0%......................
Avobenzone 2.0% ..................

            Purpose
................ Sunscreen
................ Sunscreen
................. Sunscreen
.................. Sunscreen

INDICATIONS & USAGE

Uses
■ helps prevent sunburn

WARNINGS

Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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.

DOSAGE & ADMINISTRATION

Directions

​For sunscreen use:
■ apply generously and evenly 15 minutes before sun exposure
■ children under 6 months of age: ask a doctor
■ reapply at least every 2 hours
■ use a water resistant sunscreen if swimming or sweating

STORAGE AND HANDLING

Other Information
■ protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive ingredients: WATER/EAU, GLYCERIN, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ALCOHOL, PARFUM/FRAGRANCE, PEG-40 STEARATE, PROPYLENE GLYCOL, STEARETH-2, THIODIPROPIONIC ACID, ETHOXYDIGLYCOL, SODIUM HYDROXIDE, DIMETHICONE, CARBOMER, STEARYL ALCOHOL, HYDROGENATED POLYDECENE, PHENOXYETHANOL, CAPRYLYL GLYCOL, SILICA, DISODIUM EDTA, XANTHAN GUM, TRIMETHYLSILOXYSILICATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DIMETHICONE CROSSPOLYMER, ORBIGNYA OLEIFERA SEED OIL, LECITHIN, ETHYLENE/METHACRYLATE COPOLYMER, GLYCINE SOJA (SOYBEAN) OIL, CAFFEINE, PHOSPHORIC ACID, ISOPROPYL TITANIUM TRIISOSTEARATE, TOCOPHEROL, ALGAE EXTRACT.

QUESTIONS

Questions or comments? Call 1-800-FOR-AVON.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN SO SOFT FIRM AND RESTORE  NECK AND CHEST TREATMENT
octinoxate, oxybenzone, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0331-1	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/18/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/18/2015

Labeler - New Avon LLC (080143520)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Morton Grove Inc.		116752326	manufacture(10096-0331)