Label: SUN BUM SKIN CARE ESSENTIALS KIT- avobenzone, homosalate, octisalate, octocrylene kit
- NDC Code(s): 69039-645-01, 69039-646-01
- 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 August 24, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- 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 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 (SPF 30 moisturizing sunscreen lotion)
water, polyglyceryl-6 stearate, dimethicone, cetearyl alcohol, capryloyl glycerin/sebacic acid copolymer, hydrated silica, hibiscus sabdariffa fruit extract, niacinamide, cocos nucifera (coconut) fruit extract, helianthus annuus (sunflower) extract, lactobacillus, lactobacillus ferment, musa sapientum (banana) flower extract, musa sapientum (banana) fruit extract, musa sapientum (banana) leaf extract, musa sapientum (banana) peel extract, musa sapientum (banana) pulp extract, lysolecithin, erythritol, glucose, glycerin, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, cetearyl glucoside, fragrance, polyglyceryl-6 behenate, pullulan, sclerotium gum, tocopherol, xanthan gum, phenoxyethanol, ethylhexylglycerin
- Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
SUN BUM SKIN CARE ESSENTIALS KIT
avobenzone, homosalate, octisalate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-645 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-645-01 1 in 1 KIT 08/17/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 15 mL Part 1 of 1 DAILY SUNSCREEN MOISTURIZER SPF 30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Item Code (Source) NDC:69039-646 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 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength HIBISCUS SABDARIFFA WHOLE (UNII: UH3Z91Y49Y) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) WATER (UNII: 059QF0KO0R) POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T) DIMETHICONE (UNII: 92RU3N3Y1O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) HYDRATED SILICA (UNII: Y6O7T4G8P9) NIACINAMIDE (UNII: 25X51I8RD4) COCONUT (UNII: 3RT3536DHY) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) MUSA X PARADISIACA FLOWER (UNII: DG5B0M0NGY) BANANA (UNII: 4AJZ4765R9) MUSA X PARADISIACA LEAF (UNII: 2UIJ27N6ED) BANANA PEEL (UNII: 04CM0T683C) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) ERYTHRITOL (UNII: RA96B954X6) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) GLYCERIN (UNII: PDC6A3C0OX) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) DOCOSANOL (UNII: 9G1OE216XY) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313) PULLULAN (UNII: 8ZQ0AYU1TT) BETASIZOFIRAN (UNII: 2X51AD1X3T) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-646-01 15 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 08/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/17/2021 Labeler - Sun Bum LLC (028642574)
