HEB SPF 50 ROSEWATER SCENTED CONTINUOUS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray 
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 Rosewater Scented Continuous Sunscreen Spray

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

FLAMMABLE:

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

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.

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

Other Information

Inactive Ingredients

acrylates/octylacrylamide copolymer, butylene glycol, butyloctyl salicylate, caprylic/capric triglyceride, fragrance, glycerin, panthenol, saccharomyces/podophyllum peltatum ferment filtrate, SD alcohol 40-B, tocopherol.

Label

HEB77422D

HEB SPF 50 ROSEWATER SCENTED CONTINUOUS SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PANTHENOL (UNII: WV9CM0O67Z)  
PODOPHYLLUM (UNII: 2S713A4VP3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-125-37156 g in 1 CAN; Type 0: Not a Combination Product01/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/25/2023
Labeler - H.E.B (007924756)

Revised: 3/2023
Document Id: f5db82da-fc1a-a90b-e053-2a95a90aab6c
Set id: f5db7ec6-0e9b-7044-e053-2a95a90a1e48
Version: 1
Effective Time: 20230301
 
H.E.B