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Affinia

Melaleuca, Inc.
Melaleuca, Inc.

Affinia Facial Moisturizer


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 5%

Purpose

Sunscreen

Affinia 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

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 is rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

For sunscreen use:

• apply smoothly on cleansed skin

• apply liberally 15 mintues before sun exposure

• use a water-resistant sunscreen if swimming or sweating

• reapply at least every 2 hours

• children under 6 months: Ask a doctor

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 10a.m.-2p.m. • wear long-sleeve shirts, pants, hats, and sunglasses

Affinia Other information

• for normal-to-dry skin

• dermatologist and allergy tested

• may stain some fabrics

• protect this product from excessive heat and direct sun

• do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Inactive ingredients

Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua (Water/Eau), Butyrospermum Parkii (Shea Butter), Calcium Pantothenate, Cetyl Alcohol, Citric Acid, Dimethicone, Glycerin, Glyceryl Stearate, Maltodextrin, Mangifera Indica (Mango) Seed Butter, Methylisothiazolinone, Niacinamide, Parfum, PEG-100 Stearate, Phenoxyethanol, Phenoxyethyl Caprylate, Polyacrylate-15 (and) Polyacrylate-17, Potassium Sorbate, Pyridoxine HCL, Silica, Sodium Ascorbyl Phosphate, Sodium Starch Octenylsuccinate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Xanthan Gum

Affinia

Affinia

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54473-224
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 7.296 g
OCTOCRYLENE Octocrylene 6.08 g
OCTISALATE OCTISALATE 3.648 g
AVOBENZONE AVOBENZONE 2.1888 g

Inactive Ingredients

Ingredient Name Strength
.ALPHA.-TOCOPHEROL ACETATE
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
CALCIUM PANTOTHENATE
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
COCOA BUTTER
DIMETHICONE
GLYCERIN
GLYCERYL MONOSTEARATE
GLYCERYL STEARATE SE
maltodextrin
Mangifera Indica Seed Butter
METHYLISOTHIAZOLINONE
NIACINAMIDE
PEG-100 STEARATE
PHENOXYETHANOL
PHENOXYETHYL CAPRYLATE
POTASSIUM SORBATE
PYRIDOXINE HYDROCHLORIDE
SHEANUT OIL
SILICON DIOXIDE
SODIUM ASCORBYL PHOSPHATE
SODIUM STEAROYL GLUTAMATE
TRISODIUM ETHYLENEDIAMINE DISUCCINATE
water
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE, PUMP
2 NDC:54473-224-04 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-08-01


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