ORCHIDEE IMPERIALE BRIGHTENING EXCEPTIONAL COMPLETE CARE THE BRIGHTENING AND PERFECTING UV PROTECTOR WITH SUNSCREEN BROAD SPECTRUM SPF 50 POLLUTION- octinoxate, oxybenzone, titanium dioxide cream

ORCHIDEE IMPERIALE BRIGHTENING EXCEPTIONAL COMPLETE CARE THE BRIGHTENING AND PERFECTING UV PROTECTOR WITH SUNSCREEN BROAD SPECTRUM SPF 50 POLLUTION by

Drug Labeling and Warnings

ORCHIDEE IMPERIALE BRIGHTENING EXCEPTIONAL COMPLETE CARE THE BRIGHTENING AND PERFECTING UV PROTECTOR WITH SUNSCREEN BROAD SPECTRUM SPF 50 POLLUTION 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 6.74%

Oxybenzone 2%

Titanium Dioxide 8.87%

Purpose

sunscreen

Uses

• Helps prevent sunburn

Warnings

• 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.

Stop use and ask a doctor

• if rash occurs.

Keep out of reach of children. 

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

Directions

For sunscreen use:

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every two 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: Ask a doctor.
  

Other information

• Protect this product from excessive heat and direct sun.

Question or comments?

In USA: 19 East, 57th Street, New York, NY 10022
855 454 6242 Monday through Friday 9am to 5pm EST.

Inactive ingredients

AQUA (WATER) ● C12-15 ALKYL BENZOATE ● BUTYLENE GLYCOL ● ISODODECANE ● GLYCERIN ● CI 77891 (TITANIUM DIOXIDE) ● SILICA ● VINYL DIMETHICONE/ METHICONE SILSESQUIOXANE CROSSPOLYMER ● CETYL PEG/PPG-10/1 DIMETHICONE ● ALUMINA ● ALUMINUM STEARATE ● POLYHYDROXYSTEARIC ACID ● MAGNESIUM SULFATE ● GASTRODIA ELATA ROOT EXTRACT ● PHALAENOPSIS AMABILIS EXTRACT ● DENDROBIUM NOBILE EXTRACT ● PHENOXYETHANOL ● PARFUM (FRAGRANCE) ● SORBITAN SESQUIOLEATE ● CI 77492 (IRON OXIDES) ● CAPRYLYL GLYCOL ● SYNTHETIC FLUORPHLOGOPITE ● DISTEARDIMONIUM HECTORITE ● SODIUM MYRISTOYL GLUTAMATE ● CI 77491 (IRON OXIDES) ● PROPYLENE CARBONATE ● ALUMINUM HYDROXIDE ● LINALOOL ● MORINGA PTERYGOSPERMA SEED EXTRACT ● CI 77499 (IRON OXIDES) ● BHT ● DISODIUM PHOSPHATE ● CITRONELLOL ● CITRIC ACID ● GERANIOL ● TROPAEOLUM MAJUS EXTRACT ● TIN OXIDE ● ALPHA-ISOMETHYL IONONE ● LIMONENE ● STEARIC ACID ● ETHYLHEXYLGLYCERIN ● PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE ● HEXAPEPTIDE-2 ● TOCOPHEROL 

Package Labeling:

INGREDIENTS AND APPEARANCE

ORCHIDEE IMPERIALE BRIGHTENING EXCEPTIONAL COMPLETE CARE THE BRIGHTENING AND PERFECTING UV PROTECTOR WITH SUNSCREEN BROAD SPECTRUM SPF 50 POLLUTION 
octinoxate, oxybenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49817-8001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67.4 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	88.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GASTRODIA ELATA TUBER (UNII: 08F85I5YAV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
MORINGA OLEIFERA SEED (UNII: TIX5482832)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GERANIOL (UNII: L837108USY)
TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)
STANNIC OXIDE (UNII: KM7N50LOS6)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49817-8001-1	1 in 1 BOX	03/01/2018
1		30 mL in 1 TUBE; 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)

Establishment
Name	Address	ID/FEI	Business Operations
Guerlain		266623064	manufacture(49817-8001)