drug facts

drug facts
SPL v1
SPL
SPL Set ID 13daa084-5af5-495d-b8cd-caa043806ca9
Route
topical
Published
Effective Date 2016-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octisalate (5 g) octocrylene
Inactive Ingredients
water ethylhexyl palmitate benzyl alcohol chlorphenesin glyceryl monostearate peg-100 stearate sodium hydroxide edetate disodium tocopherol diethylhexyl syringylidenemalonate aloe vera leaf sodium ascorbyl phosphate tricaprin tricaprylin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-04-06

Purpose

Sunscreen

Description

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


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

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
  • 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. to 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Ethylhexyl Palmitate, Polyglyceryl-3 Methylglucose Distearate, Propylene Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Chlorphenesin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Sodium Hydroxide, Disodium EDTA, Fragrance, Tocopherol, Diethylhexyl Syringylidenemalonate, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Caprylic/Capric Triglyceride.

Description

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

Principal Display Panel

NDC: 41250-924-56

meijer

Sport

Sunscreen lotion

Won't Run into Eyes

UVA/UVB Protection

30

Broad Spectrum

(80 Minutes)

8 FL. OZ. (236 mL)

Do Not Use

on damaged or broken skin

Active Ingredients

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

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 product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics


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

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
  • 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. to 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information (Other information)

protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Ethylhexyl Palmitate, Polyglyceryl-3 Methylglucose Distearate, Propylene Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Chlorphenesin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Sodium Hydroxide, Disodium EDTA, Fragrance, Tocopherol, Diethylhexyl Syringylidenemalonate, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Caprylic/Capric Triglyceride.

Principal Display Panel

NDC: 41250-924-56

meijer

Sport

Sunscreen lotion

Won't Run into Eyes

UVA/UVB Protection

30

Broad Spectrum

(80 Minutes)

8 FL. OZ. (236 mL)

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 10.0%

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children (Keep out of reach of children)

If product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics


Advanced Ingredient Data


Raw Label Data

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