FDA.reportPublic FDA data

TERRACOTTA SPRAY BRONZING POWDER MIST WITH SUNSCREEN SPF 10 01 LIGHT

Manufacturer
Guerlain
Effective date
2018-03-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:00:57

Label at a glance#

ProductTERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 01 LIGHT
Active ingredientOCTINOXATE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

For sunscreen use: Spray liberally and spread evenly by hand 15 minutes before sun exposure. Reapply at least every two hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months: Ask a doctor. Hold container 4 to 6 inches from the skin to apply. Do not spray directly into the face. Spray on hands then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 2.5 %

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 help 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.
  • When using this product keep away from face to avoid breathing it.

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

  • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • Pressurised container: May burst if heated. Keep away from heat/sparks/open flames/hot surfaces. No smoking. Do not spray on an open flame or other ignition source. Avoid vaporizing towards the eyes or mucous membranes. Do not pierce or burn, even after use. Protect from sunlight. Do no expose to temperatures exceeding 50°C/ 122°F. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • Spray liberally and spread evenly by hand 15 minutes before sun exposure.
  • Reapply at least every two hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months: Ask a doctor.
  • Hold container 4 to 6 inches from the skin to apply.
  • Do not spray directly into the face. Spray on hands then apply to face.
  • Do not apply in windy conditions.
  • Use in a well-ventilated area.

Inactive ingredients

INACTIVE INGREDIENT SECTION

BUTANE • AQUA (WATER) • ISOBUTANE • CYCLOPENTASILOXANE • PROPANE • NYLON-12 • COCOGLYCERIDES • SORBITAN ISOSTEARATE • GLYCERIN • CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • ALUMINUM/ MAGNESIUM HYDROXIDE STEARATE • PHENOXYETHANOL • SODIUM CHLORIDE • ZINC STEARATE • CAPRYLYL GLYCOL • POTASSIUM SORBATE • SILICA • HEXYLENE GLYCOL • DIMETHICONE • PARFUM (FRAGRANCE) • TOCOPHEROL • ASCORBYL PALMITATE • BENZYL SALICYLATE • LIMONENE • LINALOOL • ALPHAISOMETHYL IONONE • CITRONELLOL • HEXYL CINNAMAL • CINNAMYL ALCOHOL • GERANIOL • EUGENOL • [MAY CONTAIN : MICA • CI 77891 (TITANIUM DIOXIDE) • CI 77491, CI 77492, CI 77499 (IRON OXIDES) • CI 77007 (ULTRAMARINES)] (02735)

Other information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.

Question or comments?

OTC - QUESTIONS SECTION

In USA: 19 East, 57th Street, New York, NY 10022

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package 2Outer Package 2Inner Package 2Inner Package 2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133346470416239GTIN-13: 3346470416239
EAN-13: 3346470416239
GTIN storage (14 digits): 03346470416239		Outer Package 2.jpg

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49817-203249817-2032-1

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
BUTANE6LV4FOR43RIACT
WATER059QF0KO0RIACT
ISOBUTANEBXR49TP611IACT
CYCLOMETHICONE 50THT5PCI0RIACT
PROPANET75W9911L6IACT
NYLON-12446U8J075BIACT
COCO-GLYCERIDESISE9I7DNUGIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC STEARATEH92E6QA4FVIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
DIMETHICONE92RU3N3Y1OIACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBYL PALMITATEQN83US2B0NIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
CINNAMYL ALCOHOLSS8YOP444FIACT
GERANIOLL837108USYIACT
EUGENOL3T8H1794QWIACT
OCTINOXATE4Y5P7MUD51ACTIB

Source Document#

Source XML

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
ed2d394f-2c63-21b1-e053-2a95a90ac4852d30ff51-4290-4e09-a84c-9d2c70de7eb22022-11-11WarningsExact identifier
spl set id: 2d30ff51-4290-4e09-a84c-9d2c70de7eb2

Reported adverse events (FAERS/openFDA)#

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