Label: SUN BUM DAILY SUNSCREEN FACE MIST SPF30- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 69039-636-01
- 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 February 4, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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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.
- do not apply in windy conditions
- use in a well-ventilated area
- reapply: • after 40 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
- Other information
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Inactive ingredients
alcohol denat. (71%), trimethyl pentanediol/adipic acid/glycerin crosspolymer, isoamyl cocoate, musa sapientum (banana) pulp extract, musa sapientum (banana) peel extract, musa sapientum (banana) leaf extract, musa sapientum (banana) flower extract, musa sapientum (banana) fruit extract, tocopherol, niacinamide, cocos nucifera (coconut) fruit extract, glycerin, helianthus annuus (sunflower) extract, lactobacillus, lactobacillus ferment, pelvetia canaliculata extract, fragrance, water
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INGREDIENTS AND APPEARANCE
SUN BUM DAILY SUNSCREEN FACE MIST SPF30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-636 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 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q) ISOAMYL COCOATE (UNII: 14OG46E98E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) HYDRATED SILICA (UNII: Y6O7T4G8P9) BANANA PEEL (UNII: 04CM0T683C) MUSA X PARADISIACA LEAF (UNII: 2UIJ27N6ED) MUSA X PARADISIACA FLOWER (UNII: DG5B0M0NGY) BANANA (UNII: 4AJZ4765R9) TOCOPHEROL (UNII: R0ZB2556P8) NIACINAMIDE (UNII: 25X51I8RD4) COCONUT (UNII: 3RT3536DHY) GLYCERIN (UNII: PDC6A3C0OX) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) PELVETIA CANALICULATA (UNII: 8U1M44KESN) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-636-01 1 in 1 CARTON 05/19/2021 1 74 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/19/2021 Labeler - Sun Bum LLC (028642574)
