Topcare Everyday Mineral Sunscreen Continuous Spray Broad Spectrum Spf 50 Reef-conscious Formula

Topcare Everyday Mineral Sunscreen Continuous Spray Broad Spectrum Spf 50 Reef-conscious Formula
SPL v2
SPL
SPL Set ID f14f43e6-ee57-5495-e053-2a95a90a4011
Route
TOPICAL
Published
Effective Date 2022-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (35 mg) Zinc Oxide (72.5 mg)
Inactive Ingredients
Chlorphenesin Water Isohexadecane Sodium Hydroxide Cetyl Alcohol Anhydrous Citric Acid Alkyl (c12-15) Benzoate Cetearyl Glucoside Cetearyl Olivate Sodium Gluconate Medium-chain Triglycerides Isododecane Sorbitan Olivate Coco Glucoside Magnesium Sulfate Heptahydrate .alpha.-tocopherol, Dl- Safflower Oil Aloe Vera Leaf Glycerin Xanthan Gum Butyloctyl Salicylate Neopentyl Glycol Diheptanoate Jojoba Oil Shea Butter Ethyl Esters Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-17

Description

Titanium Dioxide 3.5% Zinc Oxide 7.25%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.5% Zinc Oxide 7.25%

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
Label

Warnings

​For external use only

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• hold can 4-6 inches away from skin top apply

• do not spray into face. Spray into hand and apply to face.

• use in a well ventilated areas



reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months: 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

Flammable:

• do not use near heat, flame or while smoking



• avoid long term storage above 104°F (40°C)

​do Not Use

  • ​​on damaged or broken skin

Other Information

• protect the product in the container from excessive heat and direct sun

• may stain or damage some fabrics

Active Ingredients

Titanium Dioxide 3.5%

Zinc Oxide 7.25%

Inactive Ingredients

Water, Isohexadecane, Isododecane, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Neopentyl Glycol Diheptanoate, Shea Butter Ethyl Esters, Carthamus Tinctorius (Safflower) Seed Oil, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Butyloctyl Salicylate, Coco-Glucoside, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Sorbitan Olivate, Ethylhexylglycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Chlorphenesin, Xanthan Gum, Aloe Barbadensis Leaf Juice, Tocopherol, Glycerin, Sodium Gluconate, Citric Acid.

When Using This Product

• keep out of eyes. Rinse with water to remove.

• keep away from to avoid breathing it.

• do not puncture or incinerate. Contents under pressure.

• do not store at temperatures above 120° F.

Stop Use and Ask 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.


Structured Label Content

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
Label

Purpose

Sunscreen

Warnings

​For external use only

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• hold can 4-6 inches away from skin top apply

• do not spray into face. Spray into hand and apply to face.

• use in a well ventilated areas



reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months: 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

Flammable: (FLAMMABLE:)

• do not use near heat, flame or while smoking



• avoid long term storage above 104°F (40°C)

​do Not Use (​Do not use)

  • ​​on damaged or broken skin

Other Information

• protect the product in the container from excessive heat and direct sun

• may stain or damage some fabrics

Active Ingredients (Active ingredients)

Titanium Dioxide 3.5%

Zinc Oxide 7.25%

Inactive Ingredients (Inactive ingredients)

Water, Isohexadecane, Isododecane, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Neopentyl Glycol Diheptanoate, Shea Butter Ethyl Esters, Carthamus Tinctorius (Safflower) Seed Oil, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Butyloctyl Salicylate, Coco-Glucoside, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Sorbitan Olivate, Ethylhexylglycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Chlorphenesin, Xanthan Gum, Aloe Barbadensis Leaf Juice, Tocopherol, Glycerin, Sodium Gluconate, Citric Acid.

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

• keep away from to avoid breathing it.

• do not puncture or incinerate. Contents under pressure.

• do not store at temperatures above 120° F.

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


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