H.E.B SOLUTIONS SUNSCREEN- ultra spf 50 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 Ultra SPF 50 Continuous Spray

Active ingredients

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

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, acrylates/octylacrylamide copolymer, menthyl lactate, aloe barbadensis leaf juice, tocopherol, camellia sinensis leaf extract (green tea), chamomilla recutita (matricaria) flower extract, glycerin, saccharomyces/podophyllum peltatum ferment filtrate, stearoxytrimethylsilane, caprylic/capric triglyceride, fragrance, butylene glycol, propylene glycol

Questions or Comments?

Call toll free 1-800-527-7731

H.E.B Solutions Sunscreen Ultra SPF 50 Continuous Spray

5.5 OZ (156g)

NDC 37808-974-37

Label

Label

H.E.B  SOLUTIONS SUNSCREEN
ultra spf 50 continuous spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-974
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-974-37156 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 finalpart35202/17/2012
Labeler - H.E.B (007924756)
Registrant - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of the Earth, Inc.008193513manufacture(37808-974)

Revised: 3/2020
Document Id: 89eeaf63-2d6d-4703-ba41-e6af10c79e4b
Set id: 2e183ba8-1b83-4211-bc08-dbdcee942ce9
Version: 1
Effective Time: 20200310
 
H.E.B