Label: GOODSENSE SPF 50 SUNSCREEN- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion
- NDC Code(s): 50804-083-08
- Packager: Geiss, Destin, & Dunn, Inc.
- 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 9, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Keep Out of Reach of Children.
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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 n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:
- limit time in the sun, especially from 10 am to 2 pm
- wear long-sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months: ask a doctor.
- Inactive Ingredients
- Label
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INGREDIENTS AND APPEARANCE
GOODSENSE SPF 50 SUNSCREEN
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 mL Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM (UNII: 7FLD91C86K) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) TOCOPHEROL (UNII: R0ZB2556P8) BENZYL ALCOHOL (UNII: LKG8494WBH) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-083-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/12/2020 Labeler - Geiss, Destin, & Dunn, Inc. (076059836) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs 116817470 manufacture(50804-083)
