Label: CHEMICAL SUNSCREEN SPF50- octisalate, avobenzone, homosalate, octocrylene sunscreen spray
- NDC Code(s): 60232-0043-1
- Packager: Swiss-American CDMO, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 8, 2024
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- Warnings
- Uses
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Directions
Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.
- Active Ingredients
- KEEP OUT OF REACH OF CHILDREN
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Inactive Ingredients
Water, Dicaprylyl Carbhonate, Triheptanoin C13-16 Isoalkane, Butyloctyl Salicylate, Glycerin, Ethylhexyl Methoxycrylene, Triacontanyl PVP, Phenoxyethanol, Ethylhexylglycerin, Ceterayl Alcohol, Coco-
Glucoside, Glucose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexane, Polysorbate 60, Sorbitan Isostearate. - Purpose
- Questions
- Labeling
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INGREDIENTS AND APPEARANCE
CHEMICAL SUNSCREEN SPF50
octisalate, avobenzone, homosalate, octocrylene sunscreen sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60232-0043 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 g in 1000 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 g in 1000 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 g in 1000 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 g in 1000 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ARGAN OIL (UNII: 4V59G5UW9X) TRIHEPTANOIN (UNII: 2P6O7CFW5K) COCO-GLUCOSIDE (UNII: ICS790225B) DEXTROSE (UNII: IY9XDZ35W2) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) ISOHEXADECANE (UNII: 918X1OUF1E) POLYSORBATE 60 (UNII: CAL22UVI4M) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60232-0043-1 90 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/29/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/29/2024 Labeler - Swiss-American CDMO, LLC (080170933) Registrant - Swiss-American CDMO, LLC (080170933) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 manufacture(60232-0043)