FDA.reportPublic FDA data

flawless by Sonya aloe BB creme COCOA SPF 10 Sunscreen

Manufacturer
Forever Living Products | Gotha Cosmetics SRL
Effective date
2021-04-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:39:56

Label at a glance#

Productflawless by Sonya aloe BB creme COCOA SPF 10 Sunscreen
Active ingredientTITANIUM DIOXIDE
Label structure11 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply generously and evenly 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn not skin cancer or early skin aging.
For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If products is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water/aqua/eau, dimethicone, coco-caprylate, dimethicone/vinyl dimethicone crosspolymer, talc, iron oxides (CI 77491, CI 77492, CI 77499), caprylic/capric triglyceride, cetyl peg/ppg-10/1 dimethicone, propanediol, butylene glycol, sorbitan olivate, glyceryl tribehenate/isostearate/eicosandioate, titanium dioxide (CI 77891), stearalkonium hectorite, mica, sodium chloride, phenoxyethanol, tropolone, sodium dehydroacetate, propylene carbonate, hydrogen dimethicone, alumina, enantia chlorantha bark extract, triethoxycaprylylsilane, aloe barbadensis leaf extract, fragrance/parfum, tin oxide, olea europaea (olive) leaf extract, trisodium ethylenediamine disuccinate, alcohol, maltodextrin, olea europaea (olive) fruit extract, oleanolic acid.

Other information

SPL UNCLASSIFIED SECTION

  • protect the product in the enclosed container from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-440-2563, Monday-Friday, 9:00 am to 4:00 pm PT.

FOREVER

SPL UNCLASSIFIED SECTION

This sheer aloe enriched BB Creme hydrates, primes, conceals and offers sun protection while creating a soft matte luminous glow leaving skin looking natural and flawless.

A clinically tested botanical extract helps control shine and firm and smooth skin's appearance while high-tech powders mattify and diminish the appearance of fine lines and imperfections. Olive leaf extract helps to gently even the skin tone and improve skin texture.

Manufactured exclusively for
FOREVER LIVING PRODUCTS
7501 East McCormick Parkway
Scottsdale, AZ 85258 USA
www.foreverliving.com
2012 Aloe Vera of America, Inc.
Made in Italy L21
SKU 373

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

flawless by Sonya aloe BB creme Cocoa SPF 10 Sunscreen Net Wt. 1.5 oz. (45g) 2012

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inner Package CocoaInner Package CocoaOuter Package CocoaOuter Package Cocoa

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55891-002-002023-01-30C16284748780-1ba0f9c33-171c-a910-e053-dadaa90a0b85flawless by Sonya aloe BB creme COCOA SPF 10 Sunscreen
55891-002-002021-04-22C16284748780-1ba0f9c33-171c-a910-e053-dadaa90a0b85flawless by Sonya aloe BB creme COCOA SPF 10 Sunscreen
55891-002-002021-01-29C16284748780-1ba0f9c33-171c-a910-e053-dadaa90a0b85flawless by Sonya aloe BB creme COCOA SPF 10 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55891-002-00flawless by Sonya aloe BB creme COCOA SPF 10 Sunscreen1 in 1 BOXCREAM15
55891-002-00flawless by Sonya aloe BB creme COCOA SPF 10 Sunscreen45 g in 1 TUBECREAM455

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55891-002FLAWLESS BY SONYA ALOE BB CREME COCOA SPF 10 SUNSCREEN (TITANIUM DIOXIDE) CREAM [FOREVER LIVING PRODUCTS]5Legacy NDC, 2 package rows20210424_e17504d3-0bff-401f-a55f-4cf994fc17cb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP3
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP3
ALCOHOLINACTIVE INGREDIENT3K9958V90M3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69333
ANNICKIA CHLORANTHA BARKINACTIVE INGREDIENTH70115MP4A3
BLACK OLIVEINACTIVE INGREDIENT2M6QWV94OC3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)INACTIVE INGREDIENT035JKJ76MT3
COCO-CAPRYLATEINACTIVE INGREDIENT4828G836N63
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C53
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6753
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3573
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U3
MICAINACTIVE INGREDIENTV8A1AW08803
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH473
OLEANOLIC ACIDINACTIVE INGREDIENT6SMK8R7TGJ3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T3
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51E3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X3
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971G3
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GR3
STANNIC OXIDEINACTIVE INGREDIENTKM7N50LOS63
TALCINACTIVE INGREDIENT7SEV7J4R1U3
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ03
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E3
TRISODIUM ETHYLENEDIAMINE DISUCCINATEINACTIVE INGREDIENTYA22H34H9Q3
TROPOLONEINACTIVE INGREDIENT7L6DL16P1T3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55891-00255891-002-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
COCO-CAPRYLATE4828G836N6IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
TALC7SEV7J4R1UIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
PROPANEDIOL5965N8W85TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SORBITAN OLIVATEMDL271E3GRIACT
TRIBEHENIN8OC9U7TQZ0IACT
MICAV8A1AW0880IACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TROPOLONE7L6DL16P1TIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
PROPYLENE CARBONATE8D08K3S51EIACT
ALUMINUM OXIDELMI26O6933IACT
ANNICKIA CHLORANTHA BARKH70115MP4AIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALOE VERA LEAFZY81Z83H0XIACT
STANNIC OXIDEKM7N50LOS6IACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
ALCOHOL3K9958V90MIACT
MALTODEXTRIN7CVR7L4A2DIACT
BLACK OLIVE2M6QWV94OCIACT
OLEANOLIC ACID6SMK8R7TGJIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

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 · 323 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
10 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / TOPICAL0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERINEURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii candidate
134 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XELIXIR / ORAL1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOAP / TOPICAL1.26 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAMUSCULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / RETROBULBAR648 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
10 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / EPIDURAL3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE CARBONATEPROPYLENE CARBONATE8D08K3S51EOINTMENT / TOPICAL3000 mgExact identifier — unii candidate
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / EPIDURAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / ORAL1126 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / OPHTHALMIC10 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, COATED / ORAL0.11 mgExact identifier — unii candidate
10 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / PARENTERAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / OPHTHALMIC0.08 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR45 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 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
c0949dc2-b86c-f7c2-e053-2a95a90a5fe1e17504d3-0bff-401f-a55f-4cf994fc17cb2021-04-22WarningsExact identifier
spl id: c0949dc2-b86c-f7c2-e053-2a95a90a5fe1
spl set id: e17504d3-0bff-401f-a55f-4cf994fc17cb

Reported adverse events (FAERS/openFDA)#

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