GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35- avobenzone, homosalate, octisalate 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 COSMAX USA, CORPORATION, COSMAX USA. CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone 3%

Homosalate 6%

Octisalate 5%

PURPOSE

Purpose

Sunscreen

USES

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 cause by the sun

Warnings

Warnings

For extenal use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

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 INGREDIENT

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

Other information

• Protect the product in this container from excessive heat and direct sun

QUESTIONS or COMMENTS

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

Primary Packaging

PRINCIPAL DISPLAY PANEL

Secondary Package

INGREDIENTS AND APPEARANCE

GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35 
avobenzone, homosalate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-152
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
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)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 940 (UNII: 4Q93RCW27E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BRASSICA OLERACEA VAR. BOTRYTIS WHOLE (UNII: 87M72T7VW1)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-152-01	1 in 1 CARTON	06/01/2023
1		30 mg in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2023

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA. CORPORATION		010990210	manufacture(68577-152)