Label: SUN BUM GLOW 30 MOISTURIZING SUNSCREEN FACE SPF 30- avobenzone, octisalate, octocrylene lotion
- NDC Code(s): 69039-640-01
- 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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- 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 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
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Inactive ingredients
water, bismuth oxychloride, propanediol, butyloctyl salicylate, glycerin, mica, C12-15 alkyl benzoate, polyglyceryl-6 stearate, isododecane, terminalia ferdinandiana (kakadu plum) fruit extrat, tocopherol, pullulan, lysolecithin, tetrasodium glutamate diacetate, sclerotium gum, xanthan gum, hydrated silica, titanium dioxide, polyglyceryl-6 behenate, phenoxyethanol, ethylhexylglycerin, citric acid, iron oxide
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INGREDIENTS AND APPEARANCE
SUN BUM GLOW 30 MOISTURIZING SUNSCREEN FACE SPF 30
avobenzone, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-640 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 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 WATER (UNII: 059QF0KO0R) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) PROPANEDIOL (UNII: 5965N8W85T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) MICA (UNII: V8A1AW0880) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T) ISODODECANE (UNII: A8289P68Y2) KAKADU PLUM (UNII: 0ZQ1D2FDLI) TOCOPHEROL (UNII: R0ZB2556P8) PULLULAN (UNII: 8ZQ0AYU1TT) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) BETASIZOFIRAN (UNII: 2X51AD1X3T) XANTHAN GUM (UNII: TTV12P4NEE) HYDRATED SILICA (UNII: Y6O7T4G8P9) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-640-01 1 in 1 CARTON 01/01/2022 1 59 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 01/01/2022 Labeler - Sun Bum LLC (028642574)
