H.E.B SOLUTIONS SUNSCREEN- wet protection ultra spf 85 continuous spray aerosol, 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.

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H.E.B Solutions Sunscreen Wet Protection Ultra SPF 85 Continuous Spray

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

FLAMMABLE:

   • do not use near heat, flame or while smoking

   • avoid long term storage above 104°F (40°C)

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.

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

Other information

Inactive ingredients

SD alcohol 40-B, cyclopentasiloxane, butyloctyl salicylate, octyldodecyl citrate crosspolymer, trimethylpentanediol/adipic acid/glycerin crosspolymer, ethyl methicone, bis-hydroxyethoxypropyl dimethicone, acrylates/dimethicone copolymer, fragrance, tocopheryl acetate, nelumbo nucifera flower extract, propylene glycol, ascorbyl palmitate

Questions or Comments?

Call toll free 1-800-527-7731

H.E.B Solutions Sunscreen Wet Protection Ultra SPF 85 Continuous Spray

5.5 OZ (156g)

NDC 37808-969-37

Label

H.E.B  SOLUTIONS SUNSCREEN
wet protection ultra spf 85 continuous spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-969
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) HOMOSALATE150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)  
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)  
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST) (UNII: YP714N2H05)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-969-37156 g in 1 CAN; Type 0: Not a Combination Product02/17/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/03/2012
Labeler - H.E.B (007924756)
Registrant - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of the Earth, Inc.008193513manufacture(37808-969)

Revised: 3/2020
Document Id: a0010d11-195a-4513-a917-e39769ea4249
Set id: b4abdc99-49fa-4185-b94d-56a6383d6dfa
Version: 1
Effective Time: 20200310
 
H.E.B