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NDC 00363-0996-63 Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30 300; 800; 400; 235; 500 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g Details

Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30 300; 800; 400; 235; 500 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g

Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30 is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREEN COMPANY. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	00363-0996
Product ID	0363-0996_dfc64c7b-ee5a-62a3-e053-2995a90a14a1
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	Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	300; 800; 400; 235; 500
Active Ingredient Units	mg/10g; mg/10g; mg/10g; mg/10g; mg/10g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	WALGREEN COMPANY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0996-63 (00363099663)

Pricing Information	N/A
NDC Package Code	0363-0996-63
Billing NDC	00363099663
Package	2 CAN in 1 PACKAGE (0363-0996-63) / 142 g in 1 CAN (0363-0996-24)
Marketing Start Date	2015-04-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dfc64c7b-ee59-62a3-e053-2995a90a14a1 Details

Active ingredients

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 4.0%, Octocrylene 2.35%, Oxybenzone 5.0%

Purpose

Sunscreen

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:

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

Do not use

on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120° F.

Stop use and ask doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• hold can 4-6 inches away from body, spray evenly to ensure complete coverage

• do not spray into face. Spray into hand and apply to face.

• use in well ventilated, but not windy areas

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

children under 6 months: 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. - 2 p.m.

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

Inactive ingredients

alcohol denat.,acrylates/octylacrylamide copolymer, acrylates/dimethicone copolymer, trisiloxane, dimethicone, polyester-8, PPG-5-ceteth-20, tocopherol acetate, ascorbyl palmitate, retinyl palmitate, cyclopentasiloxane, fragrance

Other Information

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

• may stain or damage some fabrics, materials or surfaces

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WELL AT WALGREENS MIST SHEER BROAD SPECTRUM BROAD SPECTRUM SPF 30

avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0996
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	300 mg in 10 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	800 mg in 10 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	400 mg in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	235 mg in 10 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	500 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRISILOXANE (UNII: 9G1ZW13R0G)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0996-63	2 in 1 PACKAGE	04/07/2015
1	NDC:0363-0996-24	142 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 not final	part352	04/07/2015

Labeler - WALGREEN COMPANY (008965063)

Revised: 5/2022

Document Id: dfc64c7b-ee5a-62a3-e053-2995a90a14a1

Set id: dfc64c7b-ee59-62a3-e053-2995a90a14a1

Version: 1

Effective Time: 20220524

Search by Drug Name or NDC

NDC 00363-0996-63 Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30 300; 800; 400; 235; 500 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g Details

Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30 300; 800; 400; 235; 500 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g

Product Information

Package

Package Images

NDC 00363-0996-63 (00363099663)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dfc64c7b-ee59-62a3-e053-2995a90a14a1 Details

Active ingredients

Purpose

Uses

Warnings

FLAMMABLE:

Do not use

When using this product

Stop use and ask doctor

Keep out of reach of children.

Directions

Inactive ingredients

Other Information

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Is It Safe To Take Ignatia Amara (Ignatius Bean) With Cymbalta?

Can You Take A Z-Pak If You Have A Penicillin Allergy?

Search by Drug Name or NDC

NDC 00363-0996-63 Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30 300; 800; 400; 235; 500 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g Details

Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30 300; 800; 400; 235; 500 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g

Product Information

Package

Package Images

NDC 00363-0996-63 (00363099663)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dfc64c7b-ee59-62a3-e053-2995a90a14a1 Details

Active ingredients

Purpose

Uses

Warnings

FLAMMABLE:

​Do not use

When using this product

Stop use and ask doctor

​Keep out of reach of children.

Directions

Inactive ingredients

Other Information

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Do not use

Keep out of reach of children.