Heb Broad Spectrum Spf 30 Coconut Scented Sunscreen Lip Balm Fh2-486-42-07

Heb Broad Spectrum Spf 30 Coconut Scented Sunscreen Lip Balm Fh2-486-42-07
SPL v3
SPL
SPL Set ID a5ef831e-7c28-7c85-e053-2995a90a9e02
Route
TOPICAL
Published
Effective Date 2024-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Octocrylene (30 mg) Avobenzone (100 mg) Homosalate
Inactive Ingredients
Candelilla Wax Alkyl (c12-15) Benzoate Paraffin Butyloctyl Salicylate Ceresin Cetyl Dimethicone 25 Caprylyl Glycol Cetyl Alcohol Mineral Oil Ascorbyl Palmitate .alpha.-tocopherol Acetate Aloe Vera Leaf Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-26

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

Label

uses

• helps prevent sunburn

Warnings

For external use only

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 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.

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

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

Inactive Ingredients

C12-15 alkyl benzoate, paraffin, butyloctyl salicylate, synthetic wax, ozokerite, euphorbia cerifera (candelilla) wax, dimethicone, flavor, aloe barbadensis leaf extract, mineral oil, ascorbyl palmitate, tocopheryl acetate, dimethicone crosspolymer-3, cetyl dimethicone, cetyl alcohol, caprylyl glycol.

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

Label

Purpose

Sunscreen

uses (Uses)

• helps prevent sunburn

Warnings

For external use only

directions (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 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.

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
Active Ingredients (Active ingredients)

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

Inactive Ingredients (Inactive ingredients)

C12-15 alkyl benzoate, paraffin, butyloctyl salicylate, synthetic wax, ozokerite, euphorbia cerifera (candelilla) wax, dimethicone, flavor, aloe barbadensis leaf extract, mineral oil, ascorbyl palmitate, tocopheryl acetate, dimethicone crosspolymer-3, cetyl dimethicone, cetyl alcohol, caprylyl glycol.

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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