Private Label Sunscreen Spf35 40min Wr Re126-202

Private Label Sunscreen Spf35 40min Wr Re126-202
SPL v1
SPL
SPL Set ID 254fa69f-2413-47e8-bc9b-5b7b0b59a5c8
Route
TOPICAL
Published
Effective Date 2023-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (90 g) Zinc Cation (100 g) Octisalate (50 g)
Inactive Ingredients
Water Edetate Disodium Sodium Chloride Xanthan Gum Phenoxyethanol Ethylhexylglycerin Medium-chain Triglycerides Dimethicone .alpha.-tocopherol Acetate Polyhydroxystearic Acid (2300 Mw) Triethoxycaprylylsilane Candelilla Wax Peg-10 Dimethicone (220 Cst) Saccharide Isomerate Glycerin Gossypium Hirsutum Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-09

Description

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.


Medication Information

Description

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Labeling

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Questions?

Call toll free 1-866-416-2366

Active Ingredients

Homosalate 9.0% Sunscreen

Zinc Oxide 10.0% Sunscreen

Octisalate 5.0% Sunscreen

Other Information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, dimethicone, PEG-10 dimethicone, euphorbia cerifera (Candelilla) Wax, Caprylic/Capric Trigylceride, sodium chloride, phenoxyethanol, polyhydroxystearic acid, triethoxycaprylylsilane, saccharide isomerate, ethylhexylglycerin, dl-alpha tocopheryl acetate, glycerin, disodium EDTA, xanthan gum, Gossypium herbaceum (Cotton) extract, citric acid, sodium citrate, benzyl alcohol, gluconolactone, sodium benzoate, calcium gluconate

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Uses (uses)

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Labeling

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Questions?

Call toll free 1-866-416-2366

Active Ingredients

Homosalate 9.0% Sunscreen

Zinc Oxide 10.0% Sunscreen

Octisalate 5.0% Sunscreen

Other Information: (Other information:)

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, dimethicone, PEG-10 dimethicone, euphorbia cerifera (Candelilla) Wax, Caprylic/Capric Trigylceride, sodium chloride, phenoxyethanol, polyhydroxystearic acid, triethoxycaprylylsilane, saccharide isomerate, ethylhexylglycerin, dl-alpha tocopheryl acetate, glycerin, disodium EDTA, xanthan gum, Gossypium herbaceum (Cotton) extract, citric acid, sodium citrate, benzyl alcohol, gluconolactone, sodium benzoate, calcium gluconate

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

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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