Walgreens SPF55 Sunscreen Reef-Conscious Formula: Package Insert and Label Information

WALGREENS SPF55 SUNSCREEN REEF-CONSCIOUS FORMULA- octisalate, homosalate, octocrylene and avobenzone stick
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.

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

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 product is swallowed, get medical help or contact a Poison Control 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 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 the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials, or surfaces

Inactive ingredients

beeswax (apis mellifera), lauryl laurate, ozokerite, cetearyl behenate, polybutene, butyloctyl salicylate, cetyl alcohol, styrene acrylates copolymer, myristyl myristate, theobroma cacao (cocoa) seed butter, phenoxyethanol, tocopherol, tetrahexyldecyl ascorbate

Labels

W05550K
(click image for full-size original)

W05550E
(click image for full-size original)
WALGREENS SPF55 SUNSCREEN REEF-CONSCIOUS FORMULA
avobenzone, homosalate, octisalate, octocrylene stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0976
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 150 mg in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 100 mg in 1 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYBUTENE (1400 MW)
ASCORBYL TETRAISOPALMITATE
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)
.ALPHA.-TOCOPHEROL, DL-
PHENOXYETHANOL
THEOBROMA CACAO WHOLE
LAURYL LAURATE
CERESIN
BUTYLOCTYL SALICYLATE
WHITE WAX
CETEARYL BEHENATE
MYRISTYL MYRISTATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0976-57 34 TUBE in 1 PACKAGE contains a TUBE (0363-0976-56)
1 NDC:0363-0976-56 17 g in 1 TUBE This package is contained within the PACKAGE (0363-0976-57)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/28/2021
Labeler — WALGREEN COMPANY (008965063)

Revised: 11/2021 WALGREEN COMPANY

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