tenacious ergodyne spf 50 sunscreen lotion

tenacious ergodyne spf 50 sunscreen lotion
SPL v4
SPL
SPL Set ID aaaa1f54-1136-4062-85ba-0926351580bb
Route
topical
Published
Effective Date 2020-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (100 mg) octocrylene (60 mg) avobenzone (30 mg)
Inactive Ingredients
water cetostearyl alcohol stearyl alcohol glycerin butyl acrylate/c16-c20 alkyl methacrylate/methacrylic acid/methyl methacrylate copolymer cetyl alcohol carbomer homopolymer type c ceteth-10 phosphate dihexadecyl phosphate coco glucoside xanthan gum edetate disodium methyl dihydroabietate sodium ascorbyl phosphate .alpha.-tocopherol acetate aloe vera leaf phenoxyethanol trolamine propylene glycol hydroxyacetophenone

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-02-13

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%


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

  • 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

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

water, cetearyl alcohol, stearyl alcohol, glycerin, acrylates/C12-22 alkyl methacrylate crosspolymer, cetyl alcohol, carbomer, ceteth-10 phosphate, dicetyl phosphate, coco-glucoside, xanthan gum, disodium EDTA, methyl dihydroabietate, lauryl PEG-8 dimethicone, phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate crosspolymer, sodium ascorbyl phosphate, tocopheryl acetate, aloe barbadensis leaf juice, phenoxyethanol, triethanolamine, propylene glycol, hydroxyacetophenone.

Description

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

Section 51945-4

Tenacious Ergodyne SPF 50 Lotion

8 FL OZ (237mL)

NDC 73620-001-11

Tenacious Ergodyne SPF 50 Lotion

1.5 OZ (44mL)

NDC 73620-001-49

Tenacious Ergodyne SPF 50 Lotion

32 FL OZ (946mL)

NDC 73620-001-72

Do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

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 swallowed, get medical help or contact a Poison Control Center right away.


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

  • 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

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
Inactive Ingredients (Inactive ingredients)

water, cetearyl alcohol, stearyl alcohol, glycerin, acrylates/C12-22 alkyl methacrylate crosspolymer, cetyl alcohol, carbomer, ceteth-10 phosphate, dicetyl phosphate, coco-glucoside, xanthan gum, disodium EDTA, methyl dihydroabietate, lauryl PEG-8 dimethicone, phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate crosspolymer, sodium ascorbyl phosphate, tocopheryl acetate, aloe barbadensis leaf juice, phenoxyethanol, triethanolamine, propylene glycol, hydroxyacetophenone.

Section 51945-4 (51945-4)

Tenacious Ergodyne SPF 50 Lotion

8 FL OZ (237mL)

NDC 73620-001-11

Tenacious Ergodyne SPF 50 Lotion

1.5 OZ (44mL)

NDC 73620-001-49

Tenacious Ergodyne SPF 50 Lotion

32 FL OZ (946mL)

NDC 73620-001-72

Do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

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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