SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 PINK GRAPEFRUIT- avobenzone, homosalate, octinoxate, octisalate stick 
Sun Bum LLC

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.

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Sun Bum Sunscreen Lip Balm Pink Grapefruit Broad Spectrum SPF 30

Active Ingredients

Avobenzone 2.00%

Homosalate 15.00%

Octinoxate 7.50%

Octissalate 5.00%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

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.

Sun Proection Measures

including:

  • Limit time in the sun, especially from 10 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

Adipic Acid / Diglycol Crosspolymer, Aloe Barbadensis Leaf Extract, Ascorbic Acid, BHT, Calendula Officinalis Flower Extract, Cameilia Sinensis Leaf Extract, Caprylic / Capric Triglyceride, Cetyl Alcohol, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cucumis Sativus (Cucumber) Fruit Extract, Cyclohexasiloxane, Cyclopentasiloxane, Diisobutyl Adipate, Dimethicone, Equisetum Extract, Hydrated Silica, Isostearyl Linoleate, Macrocystis Pyrifera (kelp) Extract, mineral Oil, Oxokarite, Panax Ginseng Root Extract, PEG-8, Polysorbate 80, Propylene Glycol, Punica Granatum (Pomegranate) Extract, Rosmarinus Officinalis (Rosemary) Extract, Saccharin, Salix Alba (Willow) Bark Extract, Salvia Officnialis (Sage) Extract, Thoabroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water.

Other information

  • Protect this product from excessive heat and direct sun.

Questions or Comments?

Call + 1 (877) 978-6286

Package Labeling

Label1

Label2

SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30  PINK GRAPEFRUIT
avobenzone, homosalate, octinoxate, octisalate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
GINKGO (UNII: 19FUJ2C58T)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
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)  
POMEGRANATE (UNII: 56687D1Z4D)  
SACCHARIN (UNII: FST467XS7D)  
WILLOW BARK (UNII: S883J9JDYX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ADIPIC ACID (UNII: 76A0JE0FKJ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LEMON PEEL (UNII: 72O054U628)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-201-011 in 1 CARTON05/12/201601/01/2021
14.25 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/12/201601/01/2021
Labeler - Sun Bum LLC (028642574)

Revised: 2/2022
 
Sun Bum LLC