Label: SUN BUM SIGNATURE SPF 30 SUNSCREEN LIP BALM- zinc oxide stick
- NDC Code(s): 69039-277-00
- 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
- 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-sleeved shirts, pants, hats, and sunglasses.
- Other Information
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Inactive Ingredients
prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, cera alba (beeswax), euphorbia cerifera (candelilla) wax, argania spinosa kernel (argan) oil, caprylic/capric triglyceride, tocopheryl acetate, copernicia cerifera (carnauba) wax, tocopherol, glycine soja (soybean) oil, glyceryl caprylate, bisabolol, polyhydroxystearic acid, polyglyceryl-3-polyricinoleate, isostearic acid, lecithin, glyceryl undecylenate
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INGREDIENTS AND APPEARANCE
SUN BUM SIGNATURE SPF 30 SUNSCREEN LIP BALM
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-277 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 80 mg in 1 g Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) JOJOBA OIL (UNII: 724GKU717M) SHEA BUTTER (UNII: K49155WL9Y) WHITE WAX (UNII: 7G1J5DA97F) CANDELILLA WAX (UNII: WL0328HX19) ARGAN OIL (UNII: 4V59G5UW9X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARNAUBA WAX (UNII: R12CBM0EIZ) TOCOPHEROL (UNII: R0ZB2556P8) SOYBEAN OIL (UNII: 241ATL177A) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) LEVOMENOL (UNII: 24WE03BX2T) ISOSTEARIC ACID (UNII: X33R8U0062) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-277-00 4.25 g in 1 TUBE; Type 0: Not a Combination Product 03/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/15/2018 Labeler - Sun Bum, LLC (028642574)
