WALGREENS SPORT BROAD SPECTRUM SPF 50 FACES SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
WALGREEN COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

WALGREENS SPORT BROAD SPECTRUM SPF 50 FACES SUNSCREEN LOTION

Active ingredients

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 5.0%, Oxybenzone 6.0%

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

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 siwmming 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 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-sleeves 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, propylene glycol, polyamide-8, neopentyl glycol diheptanoate, styrene/acrylates copolymer, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, chlorphenesin, oleth-3, tocopheryl acetate, fragrance, disodium EDTA

Questions or comments?

1-800-925-4733

WALGREENS SPORT BROAD SPECTRUM SPF 50 FACES SUNSCREEN LOTION

3.4 FL OZ (100mL)

NDC 0363-0937-66

W97742

WALGREENS SPORT BROAD SPECTRUM SPF 50 FACES SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0937
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	130 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
OLETH-3 (UNII: BQZ26235UC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0937-66	100 mL in 1 TUBE; Type 0: Not a Combination Product	10/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/31/2017	10/31/2017

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(0363-0937)

Revised: 2/2023

Document Id: f4da4779-b89c-0e2b-e053-2995a90a4722

Set id: aa092ea7-ecea-0221-e053-2a95a90a62a5

Version: 2

Effective Time: 20230216

WALGREEN COMPANY