Heb Glow 40 Tinted Sunscreen Face Primer

Heb Glow 40 Tinted Sunscreen Face Primer
SPL v1
SPL
SPL Set ID 3146bcd9-d562-9ba6-e063-6294a90a37aa
Route
TOPICAL
Published
Effective Date 2024-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Coco-caprylate/caprate Ethylhexyl Hydroxystearate Water .alpha.-tocopherol, Dl- Mica Caprylyl Glycol Titanium Dioxide Ferric Oxide Yellow Cocoa Omega-3 Fatty Acids Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Ferulic Acid Limonium Gerberi Flowering Top Trisodium Ethylenediamine Disuccinate Bismuth Oxychloride Stannic Oxide Butyloctyl Salicylate Alkyl (c12-15) Benzoate Cetyl Phosphate Chlorphenesin Diisopropyl Sebacate Isododecane Arginine Niacinamide Propanediol Isodecyl Neopentanoate Lauryl Lactate Glycerin Glyceryl 1-stearate Helianthus Annuus Flowering Top Hydroxyacetophenone Triethoxycaprylylsilane Pantothenic Acid Polymethylsilsesquioxane (11 Microns) Hyaluronate Sodium 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-18

Description

Acobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Acobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%

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
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 aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10am-2pm

• 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

Acobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredient(s)

acrylates/C10-30 alkyl acrylate crosspolymer, L-arginine, bismuth oxychloride, butyloctyl salicylate, C12-15 alkyl benzoate, calcium pantothenate, caprylic/capric triglyceride, caprylyl glycol, cetyl phosphate, chlorphenesin, coco-caprylate/caprate, diisopropyl sebacate, ethylhexyl hydroxystearate, ferulic acid, glycerin, glyceryl stearate, helianthus annuus (sunflower) flower extract, 1,2-hexanediol, hydroxyacetophenone, iron oxides, isodecyl neopentanoate, isododecane, lauryl lactate, limonium gerberi extract, mica, niacinamide, phospholipids, polymethylsilsesquioxane, propanediol, sodium hyaluronate, theobroma cacao (cocoa) seed extract, titanium dioxide, tocopherol, triethoxycaprylylsilane, trisodium ethylenediamine disuccinate, water

when Using This Product

keep out of eyes. Rinse with water to remove.

stop Use and Ask 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 protection 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 aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10am-2pm

• 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 (Active Ingredients)

Acobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredient(s)

acrylates/C10-30 alkyl acrylate crosspolymer, L-arginine, bismuth oxychloride, butyloctyl salicylate, C12-15 alkyl benzoate, calcium pantothenate, caprylic/capric triglyceride, caprylyl glycol, cetyl phosphate, chlorphenesin, coco-caprylate/caprate, diisopropyl sebacate, ethylhexyl hydroxystearate, ferulic acid, glycerin, glyceryl stearate, helianthus annuus (sunflower) flower extract, 1,2-hexanediol, hydroxyacetophenone, iron oxides, isodecyl neopentanoate, isododecane, lauryl lactate, limonium gerberi extract, mica, niacinamide, phospholipids, polymethylsilsesquioxane, propanediol, sodium hyaluronate, theobroma cacao (cocoa) seed extract, titanium dioxide, tocopherol, triethoxycaprylylsilane, trisodium ethylenediamine disuccinate, water

when Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

stop Use and Ask Doctor If (Stop use and ask 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.


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Raw Label Data

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