Flawless by Sonya Aloe BB Creme

Manufacturer
Aloe Vera of America, Inc.
Effective date
2014-01-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:38:21

Label at a glance#

ProductFlawless by Sonya Aloe BB Creme Cocoa
Active ingredientTITANIUM DIOXIDE
Label structure8 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#

OTC - ACTIVE INGREDIENT SECTION


Active Ingredient
Purpose
Titanium dioxide 3%.....................................
Sunscreen

Uses

OTC - PURPOSE SECTION

  • helps prevent sunburn

WARNINGS SECTION

Warnings

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

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 if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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



Directions

OTC - WHEN USING 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 INGREDIENT SECTION

Inactive Ingredients

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 tribehante/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

INDICATIONS & USAGE SECTION


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

OTC - QUESTIONS SECTION

Questions or comments?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cocoa bb creme box
cocoa bb creme box

cocoa bb creme tube
cocoa bb creme tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11697-373-022019-11-27C16284748780-19855e2a2-3ca5-60a7-e053-dbdaa90a05bdDrug Facts for Flawless by Sonya Aloe BB Creme - Cocoa 373

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11697-373-01Flawless by Sonya Aloe BB CremeCocoa45 g in 1 BOTTLECREAM456
11697-373-02Flawless by Sonya Aloe BB CremeCocoa1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11697-373FLAWLESS BY SONYA ALOE BB CREME COCOA (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]6Legacy NDC, 2 package rows20140213_7c801162-6c8e-4c6c-b8ff-91fb06cd2ca3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP6
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP6
ALCOHOLINACTIVE INGREDIENT3K9958V90M6
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69336
ANNICKIA CHLORANTHA BARKINACTIVE INGREDIENTH70115MP4A6
BLACK OLIVEINACTIVE INGREDIENT2M6QWV94OC6
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA6
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)INACTIVE INGREDIENTG300307ZXP6
COCO-CAPRYLATEINACTIVE INGREDIENT4828G836N66
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O6
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C56
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6756
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3576
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATEINACTIVE INGREDIENT3Y9NJ5Z7E56
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D6
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U6
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKT6
MICAINACTIVE INGREDIENTV8A1AW08806
OLEA EUROPAEA BARKINACTIVE INGREDIENT4BN4L34UKC6
OLEANOLIC ACIDINACTIVE INGREDIENT6SMK8R7TGJ6
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T6
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T6
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51E6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X6
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971G6
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GR6
STANNIC OXIDEINACTIVE INGREDIENTKM7N50LOS66
STEARALKONIUM HECTORITEINACTIVE INGREDIENTOLX698AH5P6
TALCINACTIVE INGREDIENT7SEV7J4R1U6
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E6
TRISODIUM ETHYLENEDIAMINE DISUCCINATEINACTIVE INGREDIENTYA22H34H9Q6
TROPOLONEINACTIVE INGREDIENT7L6DL16P1T6
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11697-37311697-373-01, 11697-373-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 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 · 323 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INFILTRATION3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
15 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATUMOR1.2 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVASCULARNAExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675POWDER, FOR SUSPENSION / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY, METERED / NASAL36 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / TOPICAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERINEURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SOFT TISSUE26 mgExact identifier — unii candidate
134 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / INTRAMUSCULAR9 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / EPIDURAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
15 equally ranked IID candidates
PROPYLENE CARBONATEPROPYLENE CARBONATE8D08K3S51EOINTMENT / TOPICAL3000 mgExact identifier — unii candidate
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, CHEWABLE / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii candidate
10 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY / NASAL30 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / ORALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SOLUTION / OPHTHALMIC0.9 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, EXTENDED RELEASE / ORAL335.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAOCULAR320 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS0.86 %w/vExact identifier — unii candidate
134 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
40f0d8fc-d934-4156-8f49-7ec4e266c6b67c801162-6c8e-4c6c-b8ff-91fb06cd2ca32014-01-13WarningsExact identifier
spl id: 40f0d8fc-d934-4156-8f49-7ec4e266c6b6
spl set id: 7c801162-6c8e-4c6c-b8ff-91fb06cd2ca3

Reported adverse events (FAERS/openFDA)#

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