Label: SUN BUM SIGNATURE CLEAR SPF 50- octisalate, octocrylene, zinc oxide lotion
- NDC Code(s): 69039-617-01, 69039-617-02
- 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
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
- shake well before use
- 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 value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10a.m. - 2.p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses.
- Other information
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Inactive ingredients
water, C12-15 alkyl benzoate, triethylpentanediol/ adipic acid copolymer, butyrospermum parkii (shee) butter, glycerin, polyster-8, arachidyl alcohol, panthenol, aloe barbadensis leaf juice, tocopheryl acetate, sodium hyaluronate, ascorbyl palmitate, beeswax, behenylalcohol, arachidyl glucoside, sorbitan oleate, sorbitol, lecithin, xanthan gum, oleic acid, glyceryl caprylate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, triethoxycaprylylate, disodium EDTA, phenoxyethanol, caprylyl glycol, ethylhexylglycerin
- Questions?
- Package Labeling:44ml
- Package Labeling:88ml
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INGREDIENTS AND APPEARANCE
SUN BUM SIGNATURE CLEAR SPF 50
octisalate, octocrylene, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-617 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) PANTHENOL (UNII: WV9CM0O67Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ASCORBYL PALMITATE (UNII: QN83US2B0N) YELLOW WAX (UNII: 2ZA36H0S2V) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) OLEIC ACID (UNII: 2UMI9U37CP) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-617-01 44 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/11/2020 2 NDC:69039-617-02 88 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/11/2020 Labeler - Sun Bum LLC (028642574)
