SUN BUM SPF 70 PREMIUM MOISTURIZING SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion 
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 SPF 70 Premium Moisturizing Sunscreen

Drug Facts

Active Ingredients

Avobenzone 3.00%, Homosalate 10.00%, Octinoxate 5.00%, Octisalate 5.00%, Octocrylene 10.00%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection.
  • 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.

When using this product:

Keep out of eyes.  Rinse with water to remove.

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.
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.

Other information

  • Protect this product from excessive heat and direct sun.

​Inactive Ingredients

Water, Beeswax, Hydrated Silica, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Methicone, Styrene/Acrylates Copolymer, Cetyl Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Polyester-8, Trideceth-6, Dimethicone, Ethylhexyl Stearate, Fragrance, Dimethyl Capramide, Sodium Polyacrylate, Ethylhexylglycerin, Trimethylsiloxysilicate, Xanthan Gum, BHT, Dipotassium Glycyrrhizate, Polyaminopropyl Biguanide, Tocopheryl Acetate, Disodium EDTA, Methylisothiazolinone.

Questions or Comments?

Call + 1 (877) 978-6286

Product Labeling:

SPF70_88mL

SUN BUM SPF 70 PREMIUM MOISTURIZING SUNSCREEN 
avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-223
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-223-0188 mL in 1 TUBE; Type 0: Not a Combination Product08/24/201701/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/24/201701/01/2021
Labeler - Sun Bum, LLC (028642574)

Revised: 2/2022
 
Sun Bum, LLC