Heb Spf 50 Birthday Cake Sunscreen Lotion

Heb Spf 50 Birthday Cake Sunscreen Lotion
SPL v2
SPL
SPL Set ID f5a3313e-4935-1ce3-e053-2a95a90a6ad1
Route
TOPICAL
Published
Effective Date 2021-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (45 mg) Octocrylene (80 mg)
Inactive Ingredients
Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer Sodium Ascorbyl Phosphate Water Silicon Dioxide Aluminum Starch Octenylsuccinate Ethylhexylglycerin .alpha.-tocopherol, Dl- Polyester-7 Neopentyl Glycol Diheptanoate Isododecane Butylene Glycol Potassium Hydroxide Glycerin Phenoxyethanol Carbomer Copolymer Type A Cetyl Palmitate Cetostearyl Alcohol Podophyllum Sorbitan Olivate Olive Oil Polyglyceryl-6 Esters Cetearyl Olivate Sodium Stearoyl Lactylate Sorbitan Monopalmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-22

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

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
Label

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 4.5%, Octocrylene 8.0%

inactive Ingredient(s)

water, polyester-7, neopentyl glycol diheptanoate, glycerin, cetearyl olivate, styrene/acrylates copolymer, sorbitan olivate, aluminum starch octenylsuccinate, olive oil polyglyceryl-6 esters, saccharomyces/podophyllum peltatum ferment filtrate, butylene glycol, silica, phenoxyethanol, isododecane, sodium stearoyl lactylate, cetearyl alcohol, cetyl palmitate, sorbitan palmitate, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol (vitamin E), potassium hydroxide, sodium ascorbyl phosphate, fragrance.

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

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
Label

Purpose

Sunscreen

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 (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 4.5%, Octocrylene 8.0%

inactive Ingredient(s) (Inactive Ingredient(s))

water, polyester-7, neopentyl glycol diheptanoate, glycerin, cetearyl olivate, styrene/acrylates copolymer, sorbitan olivate, aluminum starch octenylsuccinate, olive oil polyglyceryl-6 esters, saccharomyces/podophyllum peltatum ferment filtrate, butylene glycol, silica, phenoxyethanol, isododecane, sodium stearoyl lactylate, cetearyl alcohol, cetyl palmitate, sorbitan palmitate, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol (vitamin E), potassium hydroxide, sodium ascorbyl phosphate, fragrance.

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

All Sections (JSON)