HEB SOLUTIONS SUNSCREEN ULTRA 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

HEB Solutions by

Drug Labeling and Warnings

HEB Solutions by is a Otc medication manufactured, distributed, or labeled by H-E-B. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEB Solutions Sunscreen Ultra 30 Lotion – Drug Facts

Active ingredients

Avobenzone 2%, Homosalate 7%, Octisalate 5%, Octocrylene 3%, Oxybenzone 4%

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 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 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 ingredients

water, propylene glycol, 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 30 Lotion

8 FL OZ (237)

NDC: 37808-941-12

INGREDIENTS AND APPEARANCE

HEB SOLUTIONS  SUNSCREEN ULTRA 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-941
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
LAURYL ALCOHOL (UNII: 178A96NLP2)
PALMITIC ACID (UNII: 2V16EO95H1)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)
YEAST (UNII: 3NY3SM6B8U)
PODOPHYLLUM (UNII: 2S713A4VP3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-941-12	237 mL in 1 TUBE; Type 0: Not a Combination Product	10/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/09/2019

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(37808-941)