Tropical Otters Glitter Sunscreen Spf-50 - Sugar Sparkle

Tropical Otters Glitter Sunscreen Spf-50 - Sugar Sparkle
SPL v1
SPL
SPL Set ID cfd1e0c7-7e4c-41c1-8788-b73f83bf38c9
Route
TOPICAL
Published
Effective Date 2024-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octisalate (50 mg) Octocrylene (40 mg) Zinc Cation
Inactive Ingredients
Aloe Vera Leaf Water Butyloctyl Salicylate Calendula Officinalis Flower Green Tea Leaf Medium-chain Triglycerides Safflower Cetearyl Olivate Cetyl Alcohol Citric Acid Monohydrate Coconut Oil Carrot Ethylhexylglycerin Glycerin Glyceryl Monostearate Phenoxyethanol Polysorbate 20 Sorbitan Olivate .alpha.-tocopherol Acetate Corn Fd&c Blue No. 1 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-04

Description

Homosalate 10.00% Octisalate 5.00% Octocrylene 5.00% Zinc Oxide 4.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.00% Octisalate 5.00% Octocrylene 5.00% Zinc Oxide 4.00%

Uses:
  • Helps prevent sunburn. 
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of swimming or sweating.
  • 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.
Warnings:

For external use only.

Directions
  • Apply liberally15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 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-sleeved shirts, pants, hats, and sunglasses.
Do Not Use
  • on damaged or broken skin.
Drug Facts

Questions?

1-980-202-1769

Package Labeling:

Active Ingredients

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 5.00%

Zinc Oxide 4.00%

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Cosmetic Glitter (Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethane 33), Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol, FD&C Blue #1, FD&C Red #40

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts.
Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding, 

ask a health professional before use.


Structured Label Content

Uses:
  • Helps prevent sunburn. 
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of swimming or sweating.
  • 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

Warnings:

For external use only.

Directions
  • Apply liberally15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 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-sleeved shirts, pants, hats, and sunglasses.
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Questions?

1-980-202-1769

Package Labeling:

Active Ingredients

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 5.00%

Zinc Oxide 4.00%

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Cosmetic Glitter (Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethane 33), Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol, FD&C Blue #1, FD&C Red #40

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 or irritation develops and lasts.
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.

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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