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NDC 00363-0940-66 WALGREENS BROAD SPECTRUM SPF 30 DRY TOUCH SUNSCREEN 20; 70; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details

WALGREENS BROAD SPECTRUM SPF 30 DRY TOUCH SUNSCREEN 20; 70; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL

WALGREENS BROAD SPECTRUM SPF 30 DRY TOUCH SUNSCREEN is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREEN COMPANY. The primary component is AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE.

Product Information

NDC	00363-0940
Product ID	0363-0940_fa4976a7-8213-450a-b69f-eae0946956cb
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	WALGREENS BROAD SPECTRUM SPF 30 DRY TOUCH SUNSCREEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	20; 70; 75; 50; 30
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; 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 00363-0940-66 (00363094066)

Pricing Information	N/A
NDC Package Code	0363-0940-66
Billing NDC	00363094066
Package	100 mL in 1 TUBE (0363-0940-66)
Marketing Start Date	2015-11-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 56a13df5-adee-4a98-b660-8a984b895d5b Details

Active ingredients

Avobnezone 2.0%, Homosalate 7.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

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

SPL UNCLASSIFIED SECTION

Do not use • on damaged or broken skin

SPL UNCLASSIFIED SECTION

When using this product • keep out of eyes. Rinse with water to remove.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if • rash occurs.

SPL UNCLASSIFIED SECTION

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
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 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-sleeve shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun
may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, silica, adipic acid/diethylene glycol/glycerin crosspolymer, VP/hexadecene copolymer, glycerin, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, avena sativa (oat) kernel extract, squalane, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, BHT, cetyl dimethicone bisabolol, dipotassium glycyrrhizate, glyceryl stearate, PEG-100 stearate, polysorbate 60, tetrasodium EDTA, butylene glycol, trimethylsiloxysilicate, xanthan gum, benzyl alcohol, isopropylparaben, isobutylparaben, butylparaben, phenoxyethanol, fragrance

Questions or comments?

1-800-527-7731

PRINCIPAL DISPLAY PANEL

WALGREENS BROAD SPECTRUM SPF 30 DRY TOUCH SUNSCREEN LOTION

3.4 FL OZ (100mL)

NDC 0363-0940-66

INGREDIENTS AND APPEARANCE

WALGREENS BROAD SPECTRUM SPF 30 DRY TOUCH SUNSCREEN

avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0940
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
HEXADECYL POVIDONE (UNII: AG75W62QYU)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
OAT (UNII: Z6J799EAJK)
SQUALANE (UNII: GW89575KF9)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A (UNII: 81G40H8B0T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
xanthan gum (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ISOPROPYLPARABEN (UNII: A6EOX47QK0)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0940-66	100 mL in 1 TUBE; Type 0: Not a Combination Product	11/12/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/12/2015

Labeler - WALGREEN COMPANY (008965063)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Name	Address	ID/FEI	Business Operations
Establishment
FRUIT OF THE EARTH, INC.		080086802	manufacture(0363-0940)

Revised: 7/2020

Document Id: fa4976a7-8213-450a-b69f-eae0946956cb

Set id: 56a13df5-adee-4a98-b660-8a984b895d5b

Version: 1

Effective Time: 20200709

Search by Drug Name or NDC

NDC 00363-0940-66 WALGREENS BROAD SPECTRUM SPF 30 DRY TOUCH SUNSCREEN 20; 70; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details

WALGREENS BROAD SPECTRUM SPF 30 DRY TOUCH SUNSCREEN 20; 70; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL

Product Information

Package

Package Images

NDC 00363-0940-66 (00363094066)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 56a13df5-adee-4a98-b660-8a984b895d5b Details

Active ingredients

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

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