heb solutions sunscreen face 50 facial mist sunscreen

heb solutions sunscreen face 50 facial mist sunscreen
SPL v2
SPL
SPL Set ID f6cdeb2f-fc58-1780-e053-6394a90a544a
Route
topical
Published
Effective Date 2021-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octisalate (50 mg) octocrylene (25 mg)
Inactive Ingredients
alcohol acrylate/isobutyl methacrylate/n-tert-octylacrylamide copolymer (75000 mw) aloe vera leaf .alpha.-tocopherol, dl- glycerin medium-chain triglycerides butyloctyl salicylate isododecane panthenol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-03-02

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.5%


Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
  • may temporarily sting
Inactive Ingredients

acrylates/octylacrylamide copolymer, aloe barbadensis leaf juice, butyloctyl salicylate, caprylic/capric triglyceride, fragrance, glycerin, isododecane, panthenol, SD alcohol 40-B, silica silylate, tocopherol.

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.5%

Label

Flammable:

   • do not use near heat, flame or while smoking

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

directions
  • shake bottle vigorously before each use.
  • apply liberally and evenly 15 minutes before sun exposure.
  • hold bottle 6-8 inches away from face, pull hair back, close eyes, tuck lips, then spray at least 7-10 times in a circle to ensure complete coverage. Keep eyes closed for about 3 seconds after application.
  • 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 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

do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.5%

When Using This Product

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

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.


Structured Label Content

Warnings

For external use only

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
Purpose

Sunscreen

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
  • may temporarily sting
Inactive Ingredients (Inactive ingredients)

acrylates/octylacrylamide copolymer, aloe barbadensis leaf juice, butyloctyl salicylate, caprylic/capric triglyceride, fragrance, glycerin, isododecane, panthenol, SD alcohol 40-B, silica silylate, tocopherol.

Label

Flammable: (FLAMMABLE:)

   • do not use near heat, flame or while smoking

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

directions (Directions)
  • shake bottle vigorously before each use.
  • apply liberally and evenly 15 minutes before sun exposure.
  • hold bottle 6-8 inches away from face, pull hair back, close eyes, tuck lips, then spray at least 7-10 times in a circle to ensure complete coverage. Keep eyes closed for about 3 seconds after application.
  • 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 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

do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.5%

When Using This Product (When using this product)

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

stop Use and Ask A Doctor If (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.


Advanced Ingredient Data


Raw Label Data

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