NDC | 0363-8223-81, 0363-8223-82 |
Set ID | dbda6e9b-0555-4531-8c4e-bdd8122f3ee6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Walgreen Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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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
- Purpose
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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
- Helps prevent sunburn
- Warnings
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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
- Apply liberally 15 minutes before sun exposure
- Other Information
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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?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
WALG SUN MOISTURIZING SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct 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)