Label: SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 POMEGRANATE- avobenzone, homosalate, octocrylene, octisalate stick
- NDC Code(s): 69039-603-01
- 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 March 22, 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
- 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
aloe barbadensis leaf extract, argania spinosa kernel oil, bisabolol, camellia sinensis leaf extract, caprylic/capric triglyceride, calendula officinalis flower extract, cetyl alcohol, citrus grandis fruit extract, citrus limon peel extract, cucumis sativus (cucumber) fruit extract, diisobutyl adipate, equisetum arvense extract, ethylhexyl palmitate, fragrance, ginkgo biloba leaf extract, hydrogenated ethylhexyl olivate, hydrogenated olive oil unsaponifiables, isostearyl linoleate, macrocystis pyrifera extract, mineral oil, ozokerite, panax ginseng root extract, PEG-8, polysorbate 80, propylene glycol, punica granatum extract, rosmarinus officinalis extract, saccharin, salix alba (willow) bark extract, salvia officinalis (sage) extract, silica, theobroma cacao seed butter, tocopheryl acetate, tocopheryl linoleate/oleate, water
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INGREDIENTS AND APPEARANCE
SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 POMEGRANATE
avobenzone, homosalate, octocrylene, octisalate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARGAN OIL (UNII: 4V59G5UW9X) LEVOMENOL (UNII: 24WE03BX2T) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CETYL ALCOHOL (UNII: 936JST6JCN) LEMON PEEL (UNII: 72O054U628) CUCUMBER (UNII: YY7C30VXJT) DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) ETHYLHEXYL PALMITATE (UNII: 2865993309) GINKGO (UNII: 19FUJ2C58T) HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95) ISOSTEARYL LINOLEATE (UNII: 4778M3HR0N) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) MINERAL OIL (UNII: T5L8T28FGP) CERESIN (UNII: Q1LS2UJO3A) ASIAN GINSENG (UNII: CUQ3A77YXI) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) ROSEMARY (UNII: IJ67X351P9) SACCHARIN (UNII: FST467XS7D) SALIX ALBA BARK (UNII: 205MXS71H7) SAGE (UNII: 065C5D077J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-603-01 4.25 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2020 Labeler - Sun Bum LLC (028642574)
