WALG SUN MOISTURIZING SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

WALG SUN MOISTURIZING SPF 50 by

Drug Labeling and Warnings

WALG SUN MOISTURIZING SPF 50 by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

WALGREENS 50 HYDRATING MOISTURIZING BROAD SPECTRUM SUNSCREEN SPF 50 TUBE - Avobenzone, Homosalate, Octisalate, Octocrylene Lotion

WALGREENS 50 HYDRATING MOISTURIZING BROAD SPECTRUM SUNSCREEN SPF 50 TUBE 3 FL OZ (88mL) 41419-400-WG12 (PKTB-41419-WG01)

WALGREENS 50 HYDRATING MOISTURIZING BROAD SPECTRUM SUNSCREEN SPF 50 TUBE 8 FL OZ (236mL) 41420-400-WG12 (PKTB-41420-WG01)

DRUG FACTS

Active Ingredients

Avobenzone 3% (3g/100g)

Homosalate 10% (10g/100g)

Octisalate 4.5% (4.5g/100g)

Octocrylene 8% (8g/100g)

Purpose

Sunscreen

Use

• 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
  
• Re-apply:
  after 80 minutes of swimming or sweating
  immediately after towel drying
  at least every 2 hours

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 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-sleeved shirts, pants, hats and sunglasses
  
• Children under 6 months: ask a doctor

Other Information

• Protect the product in this container from excessive heat and direct sun
  
• May stain fabric

Inactive Ingredients:

Water, Glycerin, Polyglyceryl-3 Methylglucose Distearate, Cetearyl Alcohol, C28-52 Olefin/Undecylenic Acid Copolymer, Tapioca Starch, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Diisopropyl Adipate, Phenethyl Benzoate, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-100 Stearate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Polymethylsilsesquioxane, Caprylyl Glycol, Dimethicone, Fragrance, Neopentyl Glycol Diheptanoate, Hydrogenated Palm Glycerides, Trisiloxane, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Hydroxide, Disodium EDTA

Questions or comments?

1-800-925-4733

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2018 Walgreen Co.

41419-400-WG12 (PKTB-041419-WG01) REV-1118 ORG1118-F
41420-400-WG12 (PKTB-41420-WG01) REV-1118 ORG1118-F

Principal Display Panel

Walgreens

50

Hydrating

Broad Spectrum SPF 50

Sunscreen UVA/UVB

HYPOALLERGENIC

OXYBENZONE FREE

PARABEN FREE

Oil free

Water resistant

(80 minutes)

3 FL OZ (88 mL)/8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

WALG SUN MOISTURIZING SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-8223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STARCH, TAPIOCA (UNII: 24SC3U704I)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PHENETHYL BENZOATE (UNII: 0C143929GK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PEG-100 STEARATE (UNII: YD01N1999R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
TRISILOXANE (UNII: 9G1ZW13R0G)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-8223-81	88 mL in 1 TUBE; Type 0: Not a Combination Product	12/07/2018
2	NDC: 0363-8223-82	236 mL in 1 TUBE; Type 0: Not a Combination Product	12/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/07/2018

Labeler - Walgreen Company (008965063)