H.E.B: Package Insert and Label Information

H.E.B- avobenzone, homosalate, octisalate and octocrylene aerosol, 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

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protetion 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 stoage 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. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

Stop use and ask a 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
  • hold can 4-6 inches away from body, spray evenly to ensure complete coverage
  • do not spray into face. Spray into hand and apply to face.
  • use in well ventilated, but not windy areas
  • 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.

• wearl 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

SD alcohol 40-B, butyloctyl salicylate, acrylates/octylacrylamide copolymer, glycerin, saccharomyces/podophyllum peltatum ferment filtrate, caprylic/capric triglyceride, stearoxytrimethylsilane, tocopherol, panthenol, butylene glycol, fragrance

Questions or Comments?

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H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUS SPRAY

5.5 OZ (156g)

NDC 37808-910-37

LabelLabel
H.E.B
spf 50 sunscreen aerosol, spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-910
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)
TOCOPHEROL
GLYCERIN
STEAROXYTRIMETHYLSILANE
MEDIUM-CHAIN TRIGLYCERIDES
BUTYLENE GLYCOL
BUTYLOCTYL SALICYLATE
PANTHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-910-37 156 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 03/07/2019
Labeler — H.E.B (007924756)
Registrant — Fruit of the Earth, Inc. (079559467)
Establishment
Name Address ID/FEI Operations
Fruit of the Earth, Inc. 008193513 manufacture (37808-910)

Revised: 03/2020 H.E.B

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