H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 LOTION

H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 LOTION

Drug Labeling and Warnings

Drug Details

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H.E.B MANGO- spf 50 sunscreen 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.

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H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 LOTION

Active Ingredients

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

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protetion 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 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

  • children under 6 months of age: ask a doctor
  • 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 a.m. - 2 p.m.

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

Other Information

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive Ingredient(s)

water, glycerin, silica, aluminum starch octenylsuccinate, behenyl alcohol, phenoxyethanol, glyceryl stearate, arachidyl alcohol, ethylhexylglycerin, arachidyl glucoside, PEG-100 stearate, sodium ascorbyl phosphate, saccharomyces/podophyllum peltatum ferment filtrate, polyester-7, neopentyl glycol diheptanoate, styrene/acrylates copolymer, isododecane, tocopherol (vitamin E), beeswax, potassium hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, butylene glycol, fragrance

Questions or Comments?

Call toll free 1-800-527-7731

H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 LOTION

8 FL OZ (237mL)

NDC: 37808-918-12

Label

H.E.B MANGO 
spf 50 sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37808-918
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)  
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ISODODECANE (UNII: A8289P68Y2)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37808-918-12237 mL in 1 TUBE; Type 0: Not a Combination Product02/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/06/2019
Labeler - H.E.B (007924756)
Registrant - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of the Earth, Inc.008193513manufacture(37808-918)

Revised: 3/2020
 
H.E.B


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