Affinia

Manufacturer
Melaleuca, Inc.
Effective date
2023-01-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:52:57

Label at a glance#

ProductAffinia Facial Moisturizer
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure7 sections

Indications and 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

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor is rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

CLINICAL STUDIES SECTION

• for normal-to-dry skin

• dermatologist and allergy tested

GENERAL PRECAUTIONS SECTION

• may stain some fabrics

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

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 boxImage of box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-224-042025-01-30C16284748780-19d75b9d0-1051-f424-e053-dadaa90a57ceAffinia Facial Moisturizer
54473-224-042020-03-19C16284748780-19d75b9d0-1051-f424-e053-dadaa90a57ceAffinia Facial Moisturizer
54473-224-042020-01-31C16284748780-19d75b9d0-1051-f424-e053-dadaa90a57ceAffinia Facial Moisturizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-224-01AffiniaFacial Moisturizer120 mL in 1 BOTTLE, PUMPLOTION1206
54473-224-04AffiniaFacial Moisturizer1 in 1 BOXLOTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-224AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.]6Legacy NDC, 2 package rows20230106_97def817-8a7b-450d-acd3-74d2843bc92f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX3
HOMOSALATEACTIVE INGREDIENTV06SV4M95S3
OCTISALATEACTIVE INGREDIENT4X49Y0596W3
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM3
AVOBENZONEACTIVE MOIETYG63QQF2NOX3
HOMOSALATEACTIVE MOIETYV06SV4M95S3
OCTISALATEACTIVE MOIETY4X49Y0596W3
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L03
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZG3
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3D3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP3
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRR3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE43
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785I3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D3
MANGIFERA INDICA SEED BUTTERINACTIVE INGREDIENT4OXD9M35X23
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA3
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD43
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
PHENOXYETHYL CAPRYLATEINACTIVE INGREDIENTGMI5AN7T8U3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ43
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BV3
SHEANUT OILINACTIVE INGREDIENTO88E196QRF3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DR3
SODIUM STEAROYL GLUTAMATEINACTIVE INGREDIENT65A9F4P0243
TRISODIUM ETHYLENEDIAMINE DISUCCINATEINACTIVE INGREDIENTYA22H34H9Q3
WATERINACTIVE INGREDIENT059QF0KO0R3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-22454473-224-01, 54473-224-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 335 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION/ DROPS / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAMUSCULAR28 mgExact identifier — unii candidate
88 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4INJECTION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAVENOUS2068 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
15 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii candidate
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4OINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f178d444-f5ee-1aa8-e053-2a95a90ab84097def817-8a7b-450d-acd3-74d2843bc92f2023-01-04WarningsExact identifier
spl id: f178d444-f5ee-1aa8-e053-2a95a90ab840
spl set id: 97def817-8a7b-450d-acd3-74d2843bc92f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.