H.e.b. Mineral Sunscreen Broad Spectrum Spf 50 Spray
FDA Label NDC 37808-295

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H.e.b. for the product H.e.b. Mineral Sunscreen Broad Spectrum Spf 50 (NDC 37808-295). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, flammable:, ​do not use, when using this product, stop use and ask doctor if​, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Titanium Dioxide 3.5%

Zinc Oxide 7.25%

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

Flammable:

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

​Do Not Use

  • ​​on damaged or broken skin

When Using This Product

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

• keep away from to avoid breathing it.

• do not puncture or incinerate. Contents under pressure.

• do not store at temperatures above 120° F.

Stop Use And Ask Doctor If​

  • rash occurs.

Keep Out Of Reach Of Children. ​

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure
• hold can 4-6 inches away from skin top apply
• do not spray into face. Spray into hand and apply to face.
• use in a well ventilated areas

reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

• children under 6 months: 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 Value 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-sleeved shirts, pants, hats, and sunglasses

Other Information

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

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Shea Butter Ethyl Esters, Neopentyl Glycol Diheptanoate,Butyloctyl Salicylate, Simmondsia Chinensis (Jojoba) Seed Oil, Olive Oil, Polyglyceryl-6 Esters, Polyglyceryl-6 Pentaoleate, Phenoxyethanol, Stearyl/Octyldodecyl Citrate Crosspolymer, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, VP/Hexadecene Copolymer, Glycerin, Aluminum Hydroxide, Stearic Acid,Magnesium Sulfate, Glyceryl Stearate,Xanthan Gum, Ethylhexylglycerin,Tocopherol

Label

H.E.B. Mineral Sunscreen Broad Spectrum SPF 50 Continuous Spray

6.3 oz (178 g)

Heb85036d1 (Heb85036d1)

Heb85036d1 (Heb85036d1)

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