HEB Solutions Sunscreen: Package Insert and Label Information

HEB SOLUTIONS SUNSCREEN- avobenzone, homosalate, oxybenzone, octisalate and octocrylene lotion
H.E.B

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

• on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask 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 aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10am-2pm

• wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

• protect the product in this container from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive Ingredient(s)

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

HEB SOLUTIONS SUNSCREEN sport spf 100 lotion lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-951 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL HOMOSALATE (HOMOSALATE) HOMOSALATE 150 mg in 1 mL OXYBENZONE (OXYBENZONE) OXYBENZONE 60 mg in 1 mL OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength PODOPHYLLUM PELTATUM ROOT LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE WATER PROPYLENE GLYCOL SILICON DIOXIDE ALUMINUM STARCH OCTENYLSUCCINATE DOCOSANOL GLYCERYL MONOSTEARATE MICROCRYSTALLINE CELLULOSE BENZYL ALCOHOL PALMITIC ACID MYRISTYL ALCOHOL STEARIC ACID LAURYL ALCOHOL CETYL ALCOHOL ALOE VERA LEAF CHAMOMILE .ALPHA.-TOCOPHEROL, DL- LECITHIN, SOYBEAN CARBOXYMETHYLCELLULOSE SODIUM CHLORPHENESIN EDETATE DISODIUM BUTYLENE GLYCOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:37808-951-12 237 mL in 1 TUBE None 2 NDC:37808-951-79 308 mL in 1 TUBE None 3 NDC:37808-951-09 89 mL in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/05/2020

Labeler — H.E.B (007924756)

Revised: 06/2021 H.E.B