H-e-b Solutions Sunscreen Baby Spf 50 Lotion

H-e-b Solutions Sunscreen Baby Spf 50 Lotion
SPL v2
SPL
SPL Set ID 61273611-ab7a-4216-aebe-2c8d89660281
Route
TOPICAL
Published
Effective Date 2020-03-13
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
Water Docosanol Glyceryl Monostearate Microcrystalline Cellulose Myristyl Alcohol Stearic Acid Sorbic Acid Lauryl Alcohol Cetyl Alcohol Sodium Ascorbyl Phosphate Benzoic Acid Tocopherol Medium-chain Triglycerides Carboxymethylcellulose Sodium Butyloctyl Salicylate Edetate Disodium Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-05

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
Section 50565-1

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product • keep out of eyes. Rinse with water to remove.

Section 50569-3

Stop use and ask a doctor if • rash occurs.

Section 50570-1

Do not use • on damaged or broken skin.

Section 51945-4

H-E-B SOLUTIONS SUNSCREEN BABY SPF 50 LOTION

8 FL OZ (237mL)

NDC 37808-913-12

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 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-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
Active Ingredients

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

Questions Or Comments?

Call toll free 1-800-527-7731

inactive Ingredient(s)

water, butyloctyl salicylate, butylene glycol, glyceryl stearate, microcrystalline cellulose, behenyl alcohol, butylated PVP, stearic acid, lauryl alcohol, myristyl alcohol, cetyl alcohol, caprylic/capric triglyceride, tocopherol, sodium ascorbyl phosphate, cellulose gum, disodium EDTA, benzoic acid, benzoic alcohol, sorbic acid.


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
Section 50565-1 (50565-1)

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product • keep out of eyes. Rinse with water to remove.

Section 50569-3 (50569-3)

Stop use and ask a doctor if • rash occurs.

Section 50570-1 (50570-1)

Do not use • on damaged or broken skin.

Section 51945-4 (51945-4)

H-E-B SOLUTIONS SUNSCREEN BABY SPF 50 LOTION

8 FL OZ (237mL)

NDC 37808-913-12

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 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-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
Active Ingredients

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

Questions Or Comments? (Questions or Comments?)

Call toll free 1-800-527-7731

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

water, butyloctyl salicylate, butylene glycol, glyceryl stearate, microcrystalline cellulose, behenyl alcohol, butylated PVP, stearic acid, lauryl alcohol, myristyl alcohol, cetyl alcohol, caprylic/capric triglyceride, tocopherol, sodium ascorbyl phosphate, cellulose gum, disodium EDTA, benzoic acid, benzoic alcohol, sorbic acid.


Advanced Ingredient Data


Raw Label Data

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