GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35 lotion

Glossier Invisible Shield Daily Sunscreen Broad Spectrum SPF 35 by

Drug Labeling and Warnings

Glossier Invisible Shield Daily Sunscreen Broad Spectrum SPF 35 by is a Otc medication manufactured, distributed, or labeled by Glossier Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 6%

Octisalate 5%

Uses

helps prevent sunburn if used as directed with other
sun protection measures (see Directions), decreases the
risk of skin cancer and early skin aging caused by the sun

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 docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

apply generously 15 minutes before sun exposure
reapply at least every 2 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 of age: Ask a doctor

Inactive ingredients

Water, Butyloctyl Salicylate, Dipropylene Glycol, Methyl Trimethicone,
Biosaccharide Gum-4, Caprylyl Methicone, Propanediol, Bis-Ethylhexyl
Hydroxydimethoxy Benzylmalonate, Betaine, Acrylates Copolymer,
Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone,
Phenoxyethanol, Hydrolyzed Wheat Protein/PVP Crosspolymer, Dibutyl
Lauroyl Glutamide, Dibutyl Ethylhexanoyl Glutamide, Citrus Aurantium
Dulcis (Orange) Peel Oil, Dipotassium Glycyrrhizate, Carbomer, Tocopheryl
Acetate, Aminomethyl Propanol, Butylene Glycol, Hippophae Rhamnoides
Fruit Extract, Disodium EDTA, Pentylene Glycol, Aloe Barbadensis Leaf
Extract, Silica, Bioflavonoids, Potassium Sorbate, Hydroxyphenyl
Propamidobenzoic Acid, Brassica Oleracea Italica (Broccoli) Extract,
Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Ascorbyl Palmitate.

Other Information

protect the product in this container from excessive
heat and direct sun

Questions or Comments?

visit www.glossier.com or call toll-free
1-844-OK-GTEAM 1-844-654-8326

Principal Display Panel

INGREDIENTS AND APPEARANCE

GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35 
glossier invisible shield daily sunscreen broad spectrum spf 35 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71425-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CAPRYLYL TRIMETHICONE (UNII: H6HK6E4EB1)
PROPANEDIOL (UNII: 5965N8W85T)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)
BETAINE (UNII: 3SCV180C9W)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
CARBOMER 940 (UNII: 4Q93RCW27E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
BRASSICA OLERACEA VAR. BOTRYTIS WHOLE (UNII: 87M72T7VW1)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71425-010-30	1 in 1 CARTON	05/09/2017
1		30 g 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 final	part352	05/09/2017

Labeler - Glossier Inc. (078541007)