Affinia Facial Moisturizer

Affinia Facial Moisturizer

Drug Labeling and Warnings

Drug Details

k">

AFFINIA FACIAL MOISTURIZER- avobenzone, homosalate, octisalate, octocrylene 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.

----------

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 DRUGItem Code (Source)NDC: 54473-224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.296 g  in 120 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6.08 g  in 120 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.648 g  in 120 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.1888 g  in 120 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCOA BUTTER (UNII: 512OYT1CRR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENOXYETHYL CAPRYLATE (UNII: GMI5AN7T8U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SHEANUT OIL (UNII: O88E196QRF)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54473-224-041 in 1 BOX01/01/2018
1NDC: 54473-224-01120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Image of Product
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.079711683manufacture(54473-224)

Revised: 2/2018
 
Melaleuca, Inc.


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.