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NDC 00363-0936-28 WALGREENS BROAD SPECTRUM SPF 70 SUNSCREEN 30; 150; 50; 100; 30 mg/g; mg/g; mg/g; mg/g; mg/g Details

WALGREENS BROAD SPECTRUM SPF 70 SUNSCREEN 30; 150; 50; 100; 30 mg/g; mg/g; mg/g; mg/g; mg/g

WALGREENS BROAD SPECTRUM SPF 70 SUNSCREEN is a TOPICAL STICK 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	00363-0936
Product ID	0363-0936_c72ddd27-ee50-11e3-e053-2a95a90afb77
Associated GPIs	41550020102010
GCN Sequence Number	021687
GCN Sequence Number Description	cetirizine HCl SOLUTION 1 MG/ML ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	49290
HICL Sequence Number	006544
HICL Sequence Number Description	CETIRIZINE HCL
Brand/Generic	Generic
Proprietary Name	WALGREENS BROAD SPECTRUM SPF 70 SUNSCREEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	30; 150; 50; 100; 30
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g; mg/g
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 00363-0936-28 (00363093628)

Pricing Information	N/A
NDC Package Code	0363-0936-28
Billing NDC	00363093628
Package	42 g in 1 CONTAINER (0363-0936-28)
Marketing Start Date	2019-03-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aa04afcc-664e-0bc3-e053-2a95a90a134c Details

Active ingredients

Avobenzone 3%,

Homosalate 15%,

Octisalate 5%,

Octocrylene 10%,

Oxybenzone 3%

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

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.

Directions

• apply liberally 15 minutes before sun exposure

reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• 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. - 2 p.m.

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

Other information

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

• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

adipic adic/diglycol crosspolymer, beeswax, BHT, butyloctyl salicylate, C12-15 alkyl benzoate, caprylyl glycol, dimethicone, fragrance, neopentyl glycol diethylhexanoate, neopentyl glycol diisostearate, octydodecyl neopentanoate, ozokerite, paraffin, polyethylene, silica

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WALGREENS BROAD SPECTRUM SPF 70 SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0936
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CERESIN (UNII: Q1LS2UJO3A)
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PARAFFIN (UNII: I9O0E3H2ZE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WHITE WAX (UNII: 7G1J5DA97F)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0936-28	42 g in 1 CONTAINER; Type 0: Not a Combination Product	03/08/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/08/2019

Labeler - WALGREEN COMPANY (008965063)

Revised: 7/2021

Document Id: c72ddd27-ee50-11e3-e053-2a95a90afb77

Set id: aa04afcc-664e-0bc3-e053-2a95a90a134c

Version: 2

Effective Time: 20210715