Dr.c.tuna Sun Body Lotion Spf50

Dr.c.tuna Sun Body Lotion Spf50
SPL v2
SPL
SPL Set ID 250d8b0c-729b-4a0d-b6b0-2c9fdbc66197
Route
TOPICAL
Published
Effective Date 2023-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (29.5 mg) Octinoxate (73.5 mg) Homosalate (97.9 mg) Octocrylene (61.5 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Peg-100 Stearate Glyceryl Monostearate Cetostearyl Alcohol Glycerin Silicon Dioxide Cyclomethicone 5 Polyoxyl 20 Cetostearyl Ether Dicaprylyl Carbonate Ethylhexyl Palmitate Phenoxyethanol Dimethicone Ethylhexylglycerin .alpha.-tocopherol Acetate Trehalose Urea Serine Pentylene Glycol Xanthan Gum Sodium Alginate Caprylyl Glycol Hyaluronate Sodium Pullulan Edetate Disodium Anhydrous Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-03

Description

Butyl Methoxydibenzoylmethane 2.95% Ethylhexyl Methoxycinnamate 7.35% Homosalate 9.79% Octocrylene 6.15%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Butyl Methoxydibenzoylmethane 2.95% Ethylhexyl Methoxycinnamate 7.35% Homosalate 9.79% Octocrylene 6.15%

Uses
  • Helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Warnings

For external use only.

Directions
  • For Sunscreen Use
  • Apply generously 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • 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 Sun Protection Measures:
  • Limit time in the sun, especially from 10 a.m. -2 p.m.,
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.
Drug Facts:

Do Not Use 

on damaged or broken skin.

Package Labeling:

Active Ingredient:

Butyl Methoxydibenzoylmethane 2.95%

Ethylhexyl Methoxycinnamate 7.35%

Homosalate 9.79%

Octocrylene 6.15%

Other Information:
  • Protect this product from excessive heat and direct sun. May stain some fabrics.
Inactive Ingredients:

Water/Aqua, C12-15 Alkyl Benzoate, Peg-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Silica, Cyclopentasiloxane, Ceteareth-20, Dicaprylyl Carbonate, Ethylhexyl Palmitate, Phenoxyethanol, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tocopheryl Acetate, Trehalose, Urea, Serine, Pentylene Glycol, Xanthan Gum, Algin, Caprylyl Glycol, Sodium Hyaluronate, Pullulan, Disodium EDTA, Triethanolamine.

Questions Or Comments?

[email protected] Monday - Friday (9 a.m. - 9 p.m. EST) (833) 432-7627

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 ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • For Sunscreen Use
  • Apply generously 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • 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 Sun Protection Measures:
  • Limit time in the sun, especially from 10 a.m. -2 p.m.,
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.
Drug Facts:

Do Not Use  (Do not use )

on damaged or broken skin.

Package Labeling:

Active Ingredient:

Butyl Methoxydibenzoylmethane 2.95%

Ethylhexyl Methoxycinnamate 7.35%

Homosalate 9.79%

Octocrylene 6.15%

Other Information:
  • Protect this product from excessive heat and direct sun. May stain some fabrics.
Inactive Ingredients:

Water/Aqua, C12-15 Alkyl Benzoate, Peg-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Silica, Cyclopentasiloxane, Ceteareth-20, Dicaprylyl Carbonate, Ethylhexyl Palmitate, Phenoxyethanol, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tocopheryl Acetate, Trehalose, Urea, Serine, Pentylene Glycol, Xanthan Gum, Algin, Caprylyl Glycol, Sodium Hyaluronate, Pullulan, Disodium EDTA, Triethanolamine.

Questions Or Comments? (Questions or Comments?)

[email protected] Monday - Friday (9 a.m. - 9 p.m. EST) (833) 432-7627

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.


Advanced Ingredient Data


Raw Label Data

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