Label: WALGREENS 70 HYDRATING SPORT BROAD SPECTRUM SPF 70 SUNSCREEN- avobenzone. homosalate, octisalate, octocrylene lotion
- NDC Code(s): 0363-0251-14
- Packager: WALGREEN COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 25, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply 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 value 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
- Other information
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Inactive ingredients
butyloctyl salicylate, C30-38 olefin/isopropyl maleate/MA copolymer cetearyl olivate, diisopropyl sebacate, ethylhexylglycerin, glycerin, glyceryl caprylate, glyceryl stearate, isodecyl neopentanoate, lauryl lactate, neopentyl glycol diheptanoate, PEG-100 stearate, phenethyl alcohol, shea butter ethyl esters, silica, sodium hydroxide, sorbitan olivate, stearyl/octyldodecyl citrate crosspolymer, tetrasodium edta, VP/hexadecene copolymer, water , xanthan gum
- Label
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INGREDIENTS AND APPEARANCE
WALGREENS 70 HYDRATING SPORT BROAD SPECTRUM SPF 70 SUNSCREEN
avobenzone. homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0251 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) EDETATE SODIUM (UNII: MP1J8420LU) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) LAURYL LACTATE (UNII: G5SU0BFK7O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0251-14 237 mL in 1 TUBE; Type 0: Not a Combination Product 09/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 09/17/2020 Labeler - WALGREEN COMPANY (008965063)
