Label: SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 COCONUT- avobenzone, homosalate, octocrylene, octisalate stick
- NDC Code(s): 69039-602-01
- 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
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
-
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
-
Inactive Ingredients
aloe barbadensis leaf extract, argania spinosa kernel oil, bisabolol, camellia sinensis leaf extract, caprylic/capric triglyceride, cetyl alcohol, cucumis sativus (cucumber) fruit extract, diisobutyl adipate, equisetum arvense extract, ethyl hexyl palmitate, fragrance, hydrogenated ethylhexyl olivate, hydrogenated olive oil unsaponifiables, isostearyl linoleate, mineral oil, ozokerite, 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
- Questions?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 COCONUT
avobenzone, homosalate, octocrylene, octisalate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-602 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 g 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 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) CETYL ALCOHOL (UNII: 936JST6JCN) DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) ETHYLHEXYL PALMITATE (UNII: 2865993309) HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95) ISOSTEARYL LINOLEATE (UNII: 4778M3HR0N) MINERAL OIL (UNII: T5L8T28FGP) CERESIN (UNII: Q1LS2UJO3A) 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-602-01 4.25 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2019 Labeler - Sun Bum, LLC (028642574)