FDA.reportPublic FDA data

FORME COSMETICS DELICIOUS LIP BALM SPF 12

Manufacturer
CHROMAVIS SPA
Effective date
2009-10-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:22:38

Label at a glance#

ProductFORME COSMETICS DELICIOUS LIP BALM SPF 12
Active ingredientTITANIUM DIOXIDE, AVOBENZONE, OCTINOXATE
Label structure5 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 1.29%, Avobenzone 1.50%, Octinoxate 6.00%

OTC - PURPOSE SECTION

Protect and SPF12

WARNINGS SECTION

Stop use if rash occurs. As described in the Package Label-principal display area 

Other Ingredients

INACTIVE INGREDIENT SECTION

Hydrogenated polyisobutene, Cera microcristallina (Microcrystalline wax), Caprylic/Capric Triglyceride, Tridecyl Trimellitate, Polybutene, Polyethylene, Ricinus Communis oil (ricinus communis (castor) seed oil), Diisostearyl Malate, Butyrospermum Parkii butter (Butyrospermum parkii (shea Butter), Ethylhexyl palmitate,Oryzanol, Tocopheryl acetate,Tribehenin, Prunus armeniaca kernel oil (prunus armeniaca (apricot) kernel oil), Dimethicone, Cyclomethicone, Sorbitan isostearate, Ethylene/VA Copolymer, Isododecane, BHT, Lactic acid, Palmitoyl Oligopeptide, Propylparaben, Methylparaben, Aroma (Flavor)

May Contain: Mica, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxide)

Refer to the Package LabelForme Delicious Lip Balm SPF 12-3.2g-Primary Package LabelForme Delicious Lip Balm SPF 12-3.2g-Primary Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Forme

Delicious Lip Balm

Vanilla

Protect SPF 12

Stop Use if rash occurs.

Made In Italy- Distributed by Forme Cosmetics, 3600
    S. Congress Ave Suite C, Boynton Beach, FL 33426
Forme Delicious Lip Balm SPF 12-3.2g-Primary Package Label
Forme Delicious Lip Balm SPF 12-3.2g-Primary Package Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-070-012019-10-21C16284748780-1956f9ecf-db7e-621f-e053-dbdaa90a74adbdc10f9f-7e90-4794-b813-773f483a655c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49825-070-01FORME COSMETICS DELICIOUS LIP BALM SPF 123.2 g in 1 TUBELIPSTICK3.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-070FORME COSMETICS DELICIOUS LIP BALM SPF 12 (TITANIUM DIOXIDE, OCTINOXATE, AVOBENZONE) LIPSTICK [CHROMAVIS SPA]1Legacy NDC, 1 package rows20091022_bdc10f9f-7e90-4794-b813-773f483a655c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
Lactic AcidINACTIVE INGREDIENT33X04XA5AT1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49825-07049825-070-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
Lactic Acid33X04XA5ATIACT

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 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Lactic AcidLACTIC ACID33X04XA5ATINJECTION / INTRAMUSCULAR1.16 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATTABLET / ORALADJ PHExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATSOLUTION / ORAL192 mgExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATOINTMENT / TOPICALADJ PHExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATAEROSOL, FOAM / TOPICAL11 mgExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATGEL / TOPICAL30 mgExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATINJECTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCREAM / VAGINAL0.81 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATINJECTION, SOLUTION / INTRAVENOUS87 mgExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATSUSPENSION / TOPICAL0.7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATSOLUTION / TOPICAL7.22 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCREAM / TOPICAL1 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATLOTION / TOPICAL5.7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATINJECTION / INTRACARDIAC0.01 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCAPSULE / ORAL132 mgExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCONCENTRATE / ORAL50 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATSUPPOSITORY / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATINJECTION / INTRAVENOUS2232 mgExact identifier — unii candidate
18 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
cc43dbee-189a-4fa7-a813-e9755a826439bdc10f9f-7e90-4794-b813-773f483a655c2009-10-13WarningsExact identifier
spl id: cc43dbee-189a-4fa7-a813-e9755a826439
spl set id: bdc10f9f-7e90-4794-b813-773f483a655c

Reported adverse events (FAERS/openFDA)#

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