Label: DEGIL SUN SPF 30 SUNSCREEN- homosalate, octisalate, oxybenzone,avobenzone, octocrylene lotion
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NDC Code(s):
58331-060-01,
58331-060-02,
58331-060-03,
58331-060-04, view more58331-060-05
- Packager: Degil Safety Products (1989) Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 24, 2024
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- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INSTRUCTIONS FOR USE
Adults and children over 6 months of age • Apply liberally/generously (and evenly) 15 minutes before sun exposure • Reapply 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 value of 15 or higher and other sun protection measures including: ▪ limit time in the sun, especially from 11 a.m. – 3 p.m.; and ▪ wear long-sleeved shirts, pants, hats and sunglasses • Reapply after 40 minutes of swimming or sweating • Reapply immediately after towel drying
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INACTIVE INGREDIENT
Aqua,Sorbitol, Sorbitan Isostearate, Polyglyceryl-3 Distearate, Barium Sulfate, Acrylates / Octylacrylamide Copolymer, Palmitic acid, Triethanolamine, Stearic acid, Benzyl Alcohol, VP/Eicosene Copolymer, Dimethicone, Carbomer, Methyl paraben, Aloe Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Vitamin E, Propylparaben, Disodium EDTA, Propylene glycol
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEGIL SUN SPF 30 SUNSCREEN
homosalate, octisalate, oxybenzone,avobenzone, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58331-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength PALMITIC ACID (UNII: 2V16EO95H1) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITOL (UNII: 506T60A25R) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) ALOE VERA LEAF (UNII: ZY81Z83H0X) BARIUM SULFATE (UNII: 25BB7EKE2E) ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV) TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) BENZYL ALCOHOL (UNII: LKG8494WBH) JOJOBA OIL (UNII: 724GKU717M) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58331-060-01 120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 05/01/2024 2 NDC:58331-060-02 10 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 05/01/2024 3 NDC:58331-060-03 30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 05/01/2024 4 NDC:58331-060-04 180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 05/01/2024 5 NDC:58331-060-05 1000 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 05/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/01/2024 Labeler - Degil Safety Products (1989) Inc (247083686) Establishment Name Address ID/FEI Business Operations HK Kolmar Canada 243501959 manufacture(58331-060)