SPF 50 SIGNATURE HIGH PERFORMANCE SUNSCREEN- octinoxate, octisalate, octocrylene, zinc oxide 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.

----------

SPF 50 Signature High Performance Sunscreen Lotion

Drug Facts

Active Ingredients

Octinoxate 7.50%, Octisalate 5.00%, Octocrylene 7.00%, Zinc Oxide 10.00%

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.

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.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arachidyl Alcohol, Arachidyl Glucoside, Ascorbyl Palmitate, Beeswax, Behenyl Alcohol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lecithin, Methylisothiazolinone, Oleic Acid, Panthenol, Phenoxyethanol, Polyester-8, Sodium Hyaluronate, Sorbitan Oleate, Sorbitol, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylpentanediol/Adipic Acid Copolymer, Water, Xanthan Gum.

Other Information

  • Protect this product from excessive heat and direct sun.

Questions or Comments?

Call +1 (877) 9 sun Bum.

Package Labeling:

Outer Package3Inner Package3

SPF 50 SIGNATURE HIGH PERFORMANCE SUNSCREEN 
octinoxate, octisalate, octocrylene, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-209
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
DOCOSANOL (UNII: 9G1OE216XY)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
OLEIC ACID (UNII: 2UMI9U37CP)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITOL (UNII: 506T60A25R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-209-011 in 1 BOX08/25/201701/01/2021
188 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/25/201701/01/2021
Labeler - Sun Bum, LLC (028642574)

Revised: 2/2022
 
Sun Bum, LLC