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NDC 71425-0030-06 Glossier sun glaze gleaming sunscreen oil broad spectrum SPF 30 Water Resistant 40 Min 3; 15; 5; 10 g/100g; g/100g; g/100g; g/100g Details

Glossier sun glaze gleaming sunscreen oil broad spectrum SPF 30 Water Resistant 40 Min 3; 15; 5; 10 g/100g; g/100g; g/100g; g/100g

Glossier sun glaze gleaming sunscreen oil broad spectrum SPF 30 Water Resistant 40 Min is a TOPICAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Glossier Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	71425-0030
Product ID	71425-030_7a91c9f6-82c3-347a-e053-2a91aa0aab02
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Glossier sun glaze gleaming sunscreen oil broad spectrum SPF 30 Water Resistant 40 Min
Proprietary Name Suffix	n/a
Non-Proprietary Name	Glossier sun glaze gleaming sunscreen oil broad spectrum SPF 30 Water Resistant 40 Min
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	3; 15; 5; 10
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Glossier Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71425-0030-06 (71425003006)

Pricing Information	N/A
NDC Package Code	71425-030-06
Billing NDC	71425003006
Package	1 CAN in 1 PACKAGE (71425-030-06) / 167 g in 1 CAN
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 35e70dcf-a00a-4401-8127-09219931e3ac Details

Active Ingredients

Avobenzone 2.1%

Homosalate 10.50%

Octisalate 3.50%

Octocrylene 7.00%

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

Flammable: Contents under pressure. Do not puncture or incinerate.

Do not store at temperature above 120°F. Use only as directed. Intentional

misuse by deliberately con-centrating and inhaling the contents can be

harmful or fatal. Keep out of reach of children.

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: •after 40 minutes of swimming or sweating

• immediately after towel drying • at least every 2 hours

• 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

Alcohol Denat., Isobutane, Butyloctyl Salicylate, Diethylhexyl 2,6-Naphthalate, Caprylyl Methicone, Parfum/Fragrance, Acrylates/Octylacrylamide Copolymer, Mica, Dibutyl Adipate, Tocopheryl Acetate, Ascorbyl Palmitate, Mauritia Flexuosa Fruit Oil, Prunus Armeniaca (Apricot) Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Mimosa Tenuiflora Bark Extract, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides).

Other Information

• protect the product in this container from excessive

heat and direct sun

Questions or Comments?

visit Glossier.com, email us at [email protected],

or call toll-free 1-844-654-8326

Principal Display Panel

INGREDIENTS AND APPEARANCE

GLOSSIER SUN GLAZE GLEAMING SUNSCREEN OIL BROAD SPECTRUM SPF 30 WATER RESISTANT 40 MIN

glossier sun glaze gleaming sunscreen oil broad spectrum spf 30 water resistant 40 min aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71425-030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
MICA (UNII: V8A1AW0880)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
PRUNUS ARMENIACA SEED (UNII: 75356789IW)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71425-030-06	1 in 1 PACKAGE	01/01/2019
1		167 g in 1 CAN; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/01/2019

Labeler - Glossier Inc. (078541007)

Revised: 11/2018

Document Id: 7a91c9f6-82c3-347a-e053-2a91aa0aab02

Set id: 35e70dcf-a00a-4401-8127-09219931e3ac

Version: 1

Effective Time: 20181113