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 • 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 ingredients

ozokerite, C12-15 alkyl benzoate, butyloctyl salicylate, adipic acid/diglycol crosspolymer, octyldodecyl neopentanoate, polyethylene, hydroxystearic acid, beeswax, euphorbia cerifera (candelilla) wax, neopentyl glycol diethylhexanoate, neopentyl glycol diisostearate, fragrance, polyglyceryl-3 stearate, caprylyl glycol, tocopherol (vitamin E).

Questions or Comments?

Call toll free 1-800-527-7731

H.E.B Solutions Sunscreen Coconut Pineapple Scented SPF 50 Stick

1.5 OZ (42g)

NDC 37808-962-28

LabelFront LabelDrugFacts LabelDrugFacts1 LabelDrugFacts2

H.E.B SOLUTIONS SUNSCREEN
coconut pineapple scented spf 50 stick stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-962
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
YELLOW WAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37808-962-28	42 g in 1 CONTAINER; Type 0: Not a Combination Product	02/27/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/27/2019

Labeler - H.E.B (007924756)

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

Name	Address	ID/FEI	Business Operations
Establishment
Fruit of the Earth, Inc.		008193513	manufacture(37808-962)