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NDC 00363-0900-11 WALGREEN SPORT SPF 70 SUNSCREEN 30; 100; 30; 70; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details

WALGREEN SPORT SPF 70 SUNSCREEN 30; 100; 30; 70; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL

WALGREEN SPORT SPF 70 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; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	00363-0900
Product ID	0363-0900_c5ebc3e3-f7c6-9ea6-e053-2995a90a3a30
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	WALGREEN SPORT SPF 70 SUNSCREEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	30; 100; 30; 70; 60
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
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 00363-0900-11 (00363090011)

Pricing Information	N/A
NDC Package Code	0363-0900-11
Billing NDC	00363090011
Package	295 mL in 1 TUBE (0363-0900-11)
Marketing Start Date	2018-01-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a9decb0f-c041-424c-e053-2995a90a5d49 Details

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 3.0%, Octocrylene 7.0%, Oxybenzone 6.0%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection mesaures (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 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

water, propylene glycol, styrene/acrylates copolymer, silica, aluminum starch octenylsuccinate, behenyl alcohol, butylated PVP, glyceryl stearate, microcrystalline cellulose, benzyl alcohol, diethylhexyl syringylidenemalonate, caprylic/capric triglyceride, palmitic acid, myristyl alcohol, stearic acid, saccharomyces/podophyllum peltatum ferment filtrate, lauryl alcohol, cetyl alcohol, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, tocopherol (vitamin E), lecithin, cellulose gum, chlorphenesin, disodium EDTA, butylene glycol

PRINCIPAL DISPLAY PANEL

WALGREENS SPORT SPF 70 SUNSCREEN LOTION

8 FL OZ. (237mL)

NDC 0363-0900-12

WALGREENS SPORT SPF 70 SUNSCREEN LOTION

10 FL OZ. (295mL)

NDC 0363-0900-11

INGREDIENTS AND APPEARANCE

WALGREEN SPORT SPF 70 SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0900
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAURYL ALCOHOL (UNII: 178A96NLP2)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHAMOMILE (UNII: FGL3685T2X)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
WATER (UNII: 059QF0KO0R)
DOCOSANOL (UNII: 9G1OE216XY)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PALMITIC ACID (UNII: 2V16EO95H1)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CETYL ALCOHOL (UNII: 936JST6JCN)
PODOPHYLLUM PELTATUM ROOT (UNII: 2S713A4VP3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0900-12	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2018
2	NDC:0363-0900-11	295 mL in 1 TUBE; Type 0: Not a Combination Product	01/25/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/25/2018

Labeler - WALGREEN COMPANY (008965063)

Revised: 6/2021

Document Id: c5ebc3e3-f7c6-9ea6-e053-2995a90a3a30

Set id: a9decb0f-c041-424c-e053-2995a90a5d49

Version: 3

Effective Time: 20210629