Label: SUN BUM SPF 30 PREMIUM MOISTURIZING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 69039-216-01
- 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
- Apply liberally 15 minutes before sun exposure.
- Reapply: After 80 minutes of swimming or sweating.
- Immediately after towel drying.
- 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 - 2 pm.
- Wear long-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
- Other Information
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Inactive Ingredients
Water, Butyloctyl Salicylate, Hydrated Silica, VP/Hexadecene Copolymer, Styrene/Acrylates Copolymer, Dimethicone, Polyester-8, Caprylyl Methicone, Ethylhexyl Stearate, Trideceth-6, Glyceryl Stearate, PEG-100 Stearate, Fragrance, Sodium Polyacrylate, Behenyl Alcohol, Dimethyl Capramide, Ethylhexylglycerin, Trimethylsiloxysilicate, Xanthan Gum, Polyaminopropyl Biguanide, Tocopheryl Acetate, BHT, Disodium EDTA, Methylisothiazolinone.
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INGREDIENTS AND APPEARANCE
SUN BUM SPF 30 PREMIUM MOISTURIZING SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-216 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 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HYDRATED SILICA (UNII: Y6O7T4G8P9) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) DIMETHICONE (UNII: 92RU3N3Y1O) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) TRIDECETH-6 (UNII: 3T5PCR2H0C) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) DOCOSANOL (UNII: 9G1OE216XY) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-216-01 1 in 1 BOX 08/26/2017 1 177 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 08/26/2017 Labeler - Sun Bum, LLC (028642574)
