Label: SUNSCREEN SPF 30 WEGMANS- avobenzone - 3.0% homosalate - 10.0% octisalate - 5.0% octocrylene - 10.0% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 47124-450-05 - Packager: Wegman
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 4, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients Purpose
- PURPOSE
- INDICATIONS & USAGE
- Warnings
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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
• 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
• children under 6 months: Ask a doctor - Inactive ingredients
- Other information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN SPF 30 WEGMANS
avobenzone - 3.0% homosalate - 10.0% octisalate - 5.0% octocrylene - 10.0% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47124-450 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 10.0 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5.0 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 10.0 g in 100 mL Inactive Ingredients Ingredient Name Strength Benzyl Alcohol (UNII: LKG8494WBH) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Chlorphenesin (UNII: I670DAL4SZ) Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248) EDETATE DISODIUM (UNII: 7FLD91C86K) Ethylhexyl Palmitate (UNII: 2865993309) Oleth-3 (UNII: BQZ26235UC) Sodium Ascorbyl Phosphate (UNII: 836SJG51DR) Sorbitol (UNII: 506T60A25R) Tocopherol (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47124-450-05 117 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/03/2013 Labeler - Wegman (059650069) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(47124-450)
