H.E.B SOLUTIONS SUNSCREEN- spf 55 stick

H.E.B SOLUTIONS SUNSCREEN by

Drug Labeling and Warnings

H.E.B SOLUTIONS SUNSCREEN 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 15.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection 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)

beeswax, ozokertie, cetearyl behenate, lauryl lactate, polybutene, butyloctyl salicylate, cetyl alcohol, myristyl myristate, styrene/acrylates copolymer, theobroma cacao (cocoa) seed butter, phenoxyethanol, tetrahexyldecyl ascorbate (vitamin C ester), tocopherol (vitamin E).

Questions or Comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

H-E-B SOLUTIONS SUNSCREEN SPF 55 UNSCENTED KIDS SUNSCREEN STICK

1.5 OZ (42g)

NDC: 37808-926-28

INGREDIENTS AND APPEARANCE

H.E.B SOLUTIONS SUNSCREEN 
spf 55 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-926
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
YELLOW WAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETYL ALCOHOL (UNII: 936JST6JCN)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
COCOA BUTTER (UNII: 512OYT1CRR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CERESIN (UNII: Q1LS2UJO3A)
CETEARYL BEHENATE (UNII: 7ARI9LTH0U)
LAURYL LACTATE (UNII: G5SU0BFK7O)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-926-28	42 g in 1 CONTAINER; Type 0: Not a Combination Product	04/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/05/2019

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(37808-926)