Label: SUN BUM FACE 50 PREMIUM SUNSCREEN SPF 50- avobenzone, homosalte, octisalate, octocrylene lotion
- NDC Code(s): 44717-080-01
- Packager: Wasatch Product Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 14, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- shake well
- 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 Broad Spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses.
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, styrene/acrylates copolymer, dimethicone, polyester-8, tocopherol acetate, BHT, glyceryl stearate, PEG-100 stearate, ethylhexyl stearate, behenyl alcohol, caprylyl methicone, trimethylsiloxysilicate, dimethyl capramide, sodium polyacrylate, xanthan gum, trideceth-6, disodium EDTA, ethylhexylglycerin, polyaminopropyl biguanide, methylisothiazolinone
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN BUM FACE 50 PREMIUM SUNSCREEN SPF 50
avobenzone, homosalte, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44717-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) DOCOSANOL (UNII: 9G1OE216XY) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) XANTHAN GUM (UNII: TTV12P4NEE) TRIDECETH-6 (UNII: 3T5PCR2H0C) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44717-080-01 88 mL in 1 TUBE; Type 0: Not a Combination Product 02/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/01/2023 Labeler - Wasatch Product Development, LLC (962452533)
