HEB SPF 50 POMEGRANATE SUNSCREEN- avobenzone, homosalate, octisalate,octocrylene lotion 
H.E.B

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.

----------

HEB SPF 50 Pomegranate Sunscreen Lotion

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Purpose

Sunscreen

Uses

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• limit time in the sun, especially from 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

Inactive Ingredient(s)

water, polyester-7, neopentyl glycol diheptanoate, olive oil polyglyceryl-6 esters, glycerin, styrene/acrylates copolymer, aluminum starch octenylsuccinate, saccharomyces/podophyllum peltatum ferment filtrate, butylene glycol, silica, phenoxyethanol, isododecane, sodium stearoyl lactylate, cetearyl alcohol, cetearyl olivate, sorbitan olivate, cetyl palmitate, sorbitan palmitate, ethylhexylglycerin, glyceryl stearate, arachidyl alcohol, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol (vitamin E), potassium hydroxide, sodium ascorbyl phosphate, fragrance.

Label

HEB17803A1

HEB SPF 50 POMEGRANATE SUNSCREEN 
avobenzone, homosalate, octisalate,octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-043
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PEG-100 STEARATE (UNII: YD01N1999R)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ISODODECANE (UNII: A8289P68Y2)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PODOPHYLLUM (UNII: 2S713A4VP3)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-043-12237 mL in 1 TUBE; Type 0: Not a Combination Product03/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02003/10/2020
Labeler - H.E.B (007924756)

Revised: 2/2023
Document Id: f59363b2-49d4-6121-e053-2995a90a645b
Set id: f59363b2-49d3-6121-e053-2995a90a645b
Version: 1
Effective Time: 20230225
 
H.E.B