Active Ingredients
Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 5%
Affinia
FDA Label NDC 54473-224
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Affinia (NDC 54473-224). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor is rash occurs.
Otc - Keep Out Of Reach Of Children
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
General Precautions
• may stain some fabrics
Storage And Handling
• 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
Package Label.Principal Display Panel
Image Of Box (Affinamoistbox)
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