TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 01 LIGHT- octinoxate liquid

TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 by

Drug Labeling and Warnings

TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 by is a Otc medication manufactured, distributed, or labeled by Guerlain. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10   01 LIGHT
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49817-2032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49817-2032-1	1 in 1 BOX	03/01/2018
1		75 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2018

Labeler - Guerlain (266623064)