AFFINIA FACIAL MOISTURIZER- homosalate, octocrylene, octisalate and avobenzone lotion 
Melaleuca, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Affinia Facial Moisturizer

Active ingredients

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

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

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

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

Image of box

AFFINIA  FACIAL MOISTURIZER
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54473-224
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE7.296 g  in 120 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE6.08 g  in 120 mL
OCTISALATE (OCTISALATE) OCTISALATE3.648 g  in 120 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE2.1888 g  in 120 mL
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-224-041 in 1 BOX
1120 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2012
Labeler - Melaleuca, Inc. (139760102)
Registrant - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.787086842manufacture(54473-224)

Revised: 3/2013
Document Id: 5da88859-306c-4047-9303-419d519b3406
Set id: 97def817-8a7b-450d-acd3-74d2843bc92f
Version: 2
Effective Time: 20130301
 
Melaleuca, Inc.