TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 02 MEDIUM- octinoxate liquid 
Guerlain

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TERRACOTTA SPRAY BRONZING POWDER MIST WITH SUNSCREEN SPF 10 02 MEDIUM

Drug Facts

Active ingredients

Octinoxate 2.5 %

Purpose

sunscreen

Uses

  • Helps prevent sunburn

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 help prevent sunburn, not skin cancer or early skin aging.
  • For external use only.

Do not use

  • on damaged or broken skin.

When using this product

  • 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 

if rash occurs.

Keep out of reach of children.

  • 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

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

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

  • Protect this product from excessive heat and direct sun.

Question or comments?

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

Package Labeling:

Outer PackageInner Package

TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10  02 MEDIUM
octinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-2031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTANE (UNII: 6LV4FOR43R)  
WATER (UNII: 059QF0KO0R)  
ISOBUTANE (UNII: BXR49TP611)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PROPANE (UNII: T75W9911L6)  
NYLON-12 (UNII: 446U8J075B)  
COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC STEARATE (UNII: H92E6QA4FV)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
GERANIOL (UNII: L837108USY)  
EUGENOL (UNII: 3T8H1794QW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-2031-11 in 1 BOX03/01/201802/28/2019
175 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/201802/28/2019
Labeler - Guerlain (266623064)

Revised: 11/2022
 
Guerlain