H.E.B ULTRA- spf 50 sunscreen aerosol, spray

H.E.B ULTRA by

Drug Labeling and Warnings

H.E.B ULTRA by is a Otc medication manufactured, distributed, or labeled by H.E.B, Fruit of the Earth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Do not use on damaged or broken skin.

WHEN USING

When using this product  keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if  rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

Questions or Comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

H-E-B SOLUTIONS SUNSCREEN ULTRA SPF 50 LOTION

8 FL OZ (237mL)

NDC: 37808-914-12

INGREDIENTS AND APPEARANCE

H.E.B ULTRA 
spf 50 sunscreen aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-914
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-914-12	237 mL in 1 TUBE; Type 0: Not a Combination Product	02/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/05/2019

Labeler - H.E.B (007924756)

Registrant - Fruit of the Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth, Inc.		008193513	manufacture(37808-914)