Label: PREMIUM MOISTURIZING SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 69039-233-01
- Packager: Sun Bum LLC
- 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 3, 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 30
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-233 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 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 37.5 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PPG-5-CETETH-20 (UNII: 4AAN25P8P4) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-233-01 170 g in 1 CAN; Type 0: Not a Combination Product 08/09/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/09/2022 Labeler - Sun Bum LLC (028642574)
