HEB- general protection spf 100 lotion lotion

HEB by

Drug Labeling and Warnings

HEB by is a Otc medication manufactured, distributed, or labeled by H-E-B, Fruit Of The Earth, Inc., Fruit Of The Earth Research Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

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.

STOP USE

Stop use and ask doctorif  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 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

water, propylene glycol, styrene/acrylates copolymer, silica, aluminum starch octenylsuccinate, behenyl alcohol, glyceryl stearate, microcrystalline cellulose, benzyl alcohol, palmitic acid, myristyl alcohol, stearic acid, saccharomyces/podophyllum peltatum ferment filtrate, lauryl alcohol, cetyl alcohol, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, tocopherol (vitamin E), lecithin, cellulose gum, chlorphenesin, butylated PVP, disodium EDTA, butylene glycol

PRINCIPAL DISPLAY PANEL

HEB Solutions Sunscreen Ultra 100 Lotion

8 FL OZ (237)

NDC: 37808-943-12

INGREDIENTS AND APPEARANCE

HEB 
general protection spf 100 lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-943
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	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PALMITIC ACID (UNII: 2V16EO95H1)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAURYL ALCOHOL (UNII: 178A96NLP2)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-943-12	237 mL in 1 TUBE; Type 0: Not a Combination Product	11/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/12/2019

Labeler - H-E-B (007924756)

Registrant - Fruit Of The Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(37808-943)