FDA.reportPublic FDA data

CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45

Manufacturer
Chantecaille Beaute Inc
Effective date
2024-12-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:48:44

Label at a glance#

ProductCHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Label structure8 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 liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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 t...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%, OCTINOXATE 7.5%, OCTISALATE 5%, OCTOCRYLENE 2.75%

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.

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 skin rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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 10 a.m. – 2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun
  • Do not use if carton is open or if seal underneath tube cap is missing or broken

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ROSA DAMASCENA FLOWER WATER, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, POLYMETHYLSILSESQUIOXANE, POLYMETHYL METHACRYLATE, ISONONYL ISONONANOATE, GLYCERIN, DICAPRYLYL CARBONATE, METHYL METHACRYLATE CROSSPOLYMER, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PENTYLENE GLYCOL, POLYGLYCERYL-6 POLYRICINOLEATE, SODIUM CHLORIDE, POLYGLYCERYL-2 ISOSTEARATE, SORBITAN SESQUIISOSTEARATE, TETRASODIUM EDTA, TOCOPHEROL, MELISSA OFFICINALIS LEAF EXTRACT, STEARYL GLYCYRRHETINATE, CARNOSINE, LECITHIN, CAMELLIA SINENSIS LEAF EXTRACT, PRUNUS YEDOENSIS LEAF EXTRACT, CYCLODEXTRIN, CITRONELLOL, GERANIOL, PHENOXYETHANOL

Questions?

OTC - QUESTIONS SECTION

1-877-673-7080 Chantecaille.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label0Outer Label0Inner Label0Inner Label0

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42893-013-002021-12-08C16284748780-1c7ccaba7-15f0-fd44-e053-dadaa90aa01bCHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45
42893-013-002021-07-23C16284748780-1c7ccaba7-15f0-fd44-e053-dadaa90aa01bCHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42893-013-00CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 4540 mL in 1 TUBELOTION407

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42893-013CHANTECAILLE ULTRA SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [CHANTECAILLE BEAUTE INC]7Current NDC, Legacy NDC, 1 package rows20241226_d30cc344-846d-416e-ac57-4a29d4ed8263.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CARNOSINEINACTIVE INGREDIENT8HO6PVN24W1
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGV1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
ISONONYL ISONONANOATEINACTIVE INGREDIENTS4V5BS6GCX1
OCIMUM AFRICANUM LEAFINACTIVE INGREDIENT0231102WJO1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLY(METHYL METHACRYLATE; 450000 MW)INACTIVE INGREDIENTZ47NNT4J111
POLYGLYCERYL-2 MONOISOSTEARATEINACTIVE INGREDIENT7B8OE71MQC1
POLYMETHYLSILSESQUIOXANE (11 MICRONS)INACTIVE INGREDIENTZ570VEV8XK1
PRUNUS X YEDOENSIS LEAFINACTIVE INGREDIENT1Z125GA9071
ROSA DAMASCENA FLOWER OILINACTIVE INGREDIENT18920M3T131
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
STEARYL GLYCYRRHETINATEINACTIVE INGREDIENT3YYE6VJS0P1
TEA LEAFINACTIVE INGREDIENTGH42T47V241
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42893-01342893-013-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
ROSA X DAMASCENA FLOWER OIL18920M3T13IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
GLYCERINPDC6A3C0OXIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-2 ISOSTEARATE7B8OE71MQCIACT
SORBITAN SESQUIISOSTEARATEVU97D01BF9IACT
EDETATE SODIUMMP1J8420LUIACT
TOCOPHEROLR0ZB2556P8IACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
CARNOSINE8HO6PVN24WIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PRUNUS X YEDOENSIS LEAF1Z125GA907IACT
CYCLODEXTRINS7E6SK9QDT8IACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
GERANIOLL837108USYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVINJECTION, EMULSION / INTRAVENOUS12852 mgExact identifier — unii candidate
10 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVINJECTION, EMULSION / INTRAVENOUS12852 mgExact identifier — unii candidate
10 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVINJECTION / INTRAVENOUS18000 mgExact identifier — unii candidate
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS48.75 mgExact identifier — unii candidate
10 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVEMULSION / INTRAVENOUS1.2 %w/vExact identifier — unii candidate
10 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVEMULSION / INTRAVENOUS1.2 %w/vExact identifier — unii candidate
10 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVINJECTION / INTRAVENOUS18000 mgExact identifier — unii candidate
10 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVTABLET / ORAL48 mgExact identifier — unii candidate
10 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVTABLET / ORAL48 mgExact identifier — unii candidate
10 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS48.75 mgExact identifier — unii candidate
10 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
CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEChantecaille Beaute Incd30cc344-846d-416e-ac57-4a29d4ed82632024-12-24WarningsExact identifier
ndc (package): 42893-013-00
ndc (product): 42893-013
ndc11 (package): 42893001300
spl id: 2a05afc7-f44f-6a68-e063-6294a90a6e6e
spl set id: d30cc344-846d-416e-ac57-4a29d4ed8263

Reported adverse events (FAERS/openFDA)#

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