Label: PREMIUM MOISTURIZING SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 69039-234-01, 69039-234-02
- Packager: Sun Bum LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 14, 2023
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Warnings
For external use only
Flammable: do not use near heat, flame, or while smoking
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Directions
• shake well before use • hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face. • do not apply in windy conditions • use in wellventilated area. reapply: after 80 minutes of swimming or sweating • immediately after towel drying • 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
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INGREDIENTS AND APPEARANCE
PREMIUM MOISTURIZING SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-234 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 g Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PPG-5-CETETH-20 (UNII: 4AAN25P8P4) TOCOPHEROL (UNII: R0ZB2556P8) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-234-01 170 g in 1 CAN; Type 0: Not a Combination Product 08/09/2022 2 NDC:69039-234-02 142 g in 1 CAN; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/09/2022 Labeler - Sun Bum LLC (028642574)
