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NDC 00363-0976-57 Walgreens SPF55 Sunscreen Reef-Conscious Formula 30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g Details

Walgreens SPF55 Sunscreen Reef-Conscious Formula 30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g

Walgreens SPF55 Sunscreen Reef-Conscious Formula 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.

Product Information

NDC	00363-0976
Product ID	0363-0976_cfeaf245-41b0-644d-e053-2995a90a4a34
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 SPF55 Sunscreen Reef-Conscious Formula
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	30; 150; 50; 100
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
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 00363-0976-57 (00363097657)

Pricing Information	N/A
NDC Package Code	0363-0976-57
Billing NDC	00363097657
Package	34 TUBE in 1 PACKAGE (0363-0976-57) / 17 g in 1 TUBE (0363-0976-56)
Marketing Start Date	2021-05-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cfd7c1b0-cfc3-074f-e053-2995a90a5edb Details

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

INGREDIENTS AND APPEARANCE

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

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

Ingredient Name	Strength
Inactive Ingredients
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
LAURYL LAURATE (UNII: GPW77G0937)
CERESIN (UNII: Q1LS2UJO3A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
WHITE WAX (UNII: 7G1J5DA97F)
CETEARYL BEHENATE (UNII: 7ARI9LTH0U)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0976-57	34 in 1 PACKAGE	05/28/2021
1	NDC:0363-0976-56	17 g in 1 TUBE; 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	05/28/2021

Labeler - WALGREEN COMPANY (008965063)

Revised: 11/2021

Document Id: cfeaf245-41b0-644d-e053-2995a90a4a34

Set id: cfd7c1b0-cfc3-074f-e053-2995a90a5edb

Version: 3

Effective Time: 20211102