GLOSSIER INVISIBLE SHIELD SPF 50 gel

Glossier Invisible Shield SPF 50 by

Drug Labeling and Warnings

Glossier Invisible Shield SPF 50 by is a Otc medication manufactured, distributed, or labeled by Autumn Harp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3% - Sunscreen

Homosalate 7% - Sunscreen

Octisalae 5% - Sunscreen

Octocrylene 10% - Sunscreen

PURPOSE

Use: 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.

KEEP OUT OF REACH OF CHILDREN

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

INSTRUCTIONS FOR USE

Apply generously 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating.

Children under 6 months of age: ask a doctor.

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. - 2p.m.

- wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

Inactive Ingredients: Isododecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polysilicone-22, Dimethicone Crosspolymer, Dicaprylyl Ether, Glycine Soja (Soybean) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Polyglyceryl-3 Diisostearate, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Aloe Barbadensis Leaf Extract, Bisabolol, Tocopherol, Zingiber Officinale (Ginger) Root Extract.

OTHER SAFETY INFORMATION

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

QUESTIONS

gTEAM@glossier.com

DOSAGE & ADMINISTRATION

Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: ask a doctor.

INDICATIONS & USAGE

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.

Other information: Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GLOSSIER INVISIBLE SHIELD SPF 50 
glossier invisible shield spf 50 gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0368
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SAFFLOWER OIL (UNII: 65UEH262IS)
FARNESOL (UNII: EB41QIU6JL)
SOYBEAN OIL (UNII: 241ATL177A)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
RICE GERM (UNII: 7N2B70SFEZ)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0368-2	50 in 1 CARTON	06/01/2024
1	NDC: 51514-0368-1	43 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 Drug	M020	06/01/2024

Labeler - Autumn Harp (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp		064187883	manufacture(51514-0368)