METEORITES BABY GLOW BROAD SPECTRUM SPF 25 4 GOLDEN- octinoxate, titanium dioxide cream

METEORITES BABY GLOW BROAD SPECTRUM SPF 25 4 GOLDEN by

Drug Labeling and Warnings

METEORITES BABY GLOW BROAD SPECTRUM SPF 25 4 GOLDEN by is a Otc medication manufactured, distributed, or labeled by Guerlain. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUERLAIN METEORITES BABY GLOW BROAD SPECTRUM SPF 25 4 GOLDEN

Active ingredients

Octinoxate 5.49%

Titanium Dioxide 2.19%

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.

Inactive ingredients

AQUA (WATER) CYCLOPENTASILOXANE GLYCERIN  ISODODECANE PENTYLENE GLYCOL ALCOHOL  DIMETHICONE PEG-10 DIMETHICONE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE SORBITAN SESQUIOLEATE  DISTEARDIMONIUM HECTORITE PHENOXYETHANOL  CHONDRUS CRISPUS (CARRAGEENAN) ACRYLATES/DIMETHICONE COPOLYMER SILICA OLYMETHYLSILSESQUIOXANE
PARFUM (FRAGRANCE) ALUMINUM HYDROXIDE  SODIUM MYRISTOYL GLUTAMATE STEARIC ACID  SILICA SILYLATE PROPYLENE CARBONATE TOCOPHERYL ACETATE ALPHA-ISOMETHYL IONONE BENZYL BENZOATE  SYNTHETIC FLUORPHLOGOPITE BHT LINALOOL BENZYL ALCOHOL DIAMOND POWDER LIMONENE AMYL CINNAMAL TOCOPHEROL BUTYLPHENYL METHYLPROPIONAL  GERANIOL [MAY CONTAIN : CI 77891 (TITANIUM DIOXIDE) CI 77491 (IRON OXIDES) CI 77492 (IRON OXIDES)  CI 77499 (IRON OXIDES)] (08890)

Other information

• Protect this product from excessive heat and direct sun.

Questions or comments?

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

PRODUCT LABELS

INGREDIENTS AND APPEARANCE

METEORITES BABY GLOW BROAD SPECTRUM SPF 25 4 GOLDEN 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49817-0085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	54.9 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	21.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIAMOND (UNII: 6GRV67N0U2)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
GERANIOL (UNII: L837108USY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49817-0085-1	1 in 1 CARTON	10/20/2014
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	10/20/2014

Labeler - Guerlain (266623064)

Establishment
Name	Address	ID/FEI	Business Operations
Guerlain		266623064	manufacture(49817-0085)