SKIN SO SOFT DD BODY- octisalate, oxybenzone, avobenzone, octocrylene cream

Skin So Soft by

Drug Labeling and Warnings

Skin So Soft 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 ingredient
Octisalate 4.75%.............................
Oxybenzone 4.0%...........................
Avobenzone 2.8%...........................
Octocrylene 2.5%.............................

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

.................................Sunscreen

.................................Sunscreen

.................................Sunscreen

INDICATIONS & USAGE

Uses
helps prevent sunburn

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

For sunscreen use:
apply liberally 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

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 longsleeved shirts, pants, hats and sunglasses

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, PROPYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ALCOHOL, PEG-40 STEARATE, STEARETH-2, THIODIPROPIONIC ACID, DIMETHICONE, ETHOXYDIGLYCOL, STEARYL ALCOHOL, SODIUM HYDROXIDE, HYDROGENATED POLYDECENE, PHENOXYETHANOL, CAPRYLYL GLYCOL, CARBOMER, PARFUM/FRAGRANCE, DISODIUM EDTA, XANTHAN GUM, TRIMETHYLSILOXYSILICATE, DIMETHICONE CROSSPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PUNICA GRANATUM FRUIT JUICE, SILICA, ORBIGNYA OLEIFERA SEED OIL, LECITHIN, GLYCINE SOJA (SOYBEAN) OIL, CAFFEINE, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, TOCOPHERYL ACETATE, PHOSPHORIC ACID, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED EXTRACT, TOCOPHEROL, ALGAE EXTRACT, MICA/CI 77019, TITANIUM DIOXIDE/CI 77891.

QUESTIONS

Questions or Comments?
Call toll free 1-800-FOR-AVON or 1-800-265-AVON in Canada

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN SO SOFT  DD BODY
octisalate, oxybenzone, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0317
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25 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: 10096-0317-1	200 mL in 1 TUBE; Type 0: Not a Combination Product	12/12/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/12/2013

Labeler - New Avon LLC (080143520)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Morton Grove Inc		116752326	manufacture(10096-0317)