H.E.B. Mineral Sunscreen Broad Spectrum SPF 50: Package Insert and Label Information

H.E.B. MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide spray
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

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
(click image for full-size original)
H.E.B. MINERAL SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide, zinc oxide spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-295
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 35 mg in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 72.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
STEARIC ACID
MAGNESIUM SULFATE HEPTAHYDRATE
.ALPHA.-TOCOPHEROL, DL-
OLIVE OIL POLYGLYCERYL-6 ESTERS
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
ALOE VERA LEAF
GLYCERIN
XANTHAN GUM
BUTYLOCTYL SALICYLATE
NEOPENTYL GLYCOL DIHEPTANOATE
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER
GLYCERYL 1-STEARATE
JOJOBA OIL
SHEA BUTTER ETHYL ESTERS
ALUMINUM HYDROXIDE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-295-50 179 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/22/2020
Labeler — H.E.B. (007924756)

Revised: 06/2021 H.E.B.

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