Hand Screen Broad Spectrum Sunscreen Spf 40

Hand Screen Broad Spectrum Sunscreen Spf 40
SPL v7
SPL
SPL Set ID 972ebab9-3f2f-6716-e053-2a95a90a5c75
Route
TOPICAL
Published
Effective Date 2019-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Avobenzone (3 g) Octocrylene (10 g)
Inactive Ingredients
Mandarin Oil Soybean Oil Tocopherol Cymbopogon Schoenanthus Oil Isodecyl Neopentanoate Chlorphenesin Cetyl Esters Wax Glycerin Alkyl (c12-15) Benzoate Isododecane Meadowfoam Seed Oil Hippophae Rhamnoides Fruit Oil Cardamom Oil Water Xanthan Gum Diethylhexyl Syringylidenemalonate Eucalyptus Oil Glyceryl Stearate Citrate Helianthus Annuus Seed Wax Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Argan Oil Medium-chain Triglycerides Clove Leaf Oil Plantago Lanceolata Leaf Lauryl Lactate Arginine Polymethylsilsesquioxane (4.5 Microns) Cetostearyl Alcohol 1,2-hexanediol Caprylyl Glycol Hydroxyacetophenone Propanediol Chinese Cinnamon Leaf Oil Vanillin Coco-glycerides Cetyl Phosphate Diisopropyl Sebacate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-12

Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen


Medication Information

Warnings and Precautions

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

Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and Administration

Directions

  • Apply generously and evenly 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply 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 value of 15 or higher and other sun
  • protection measures including: • limit your 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.
Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen

Section 50565-1

Keep out of reach of children

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

Section 51727-6

Inactive Ingredients

Water, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Propanediol, Glyceryl Stearate Citrate, Cocoglycerides, Isododecane, Cetyl Esters, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Arginine, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Polymethylsilsequioxane, Raphanus Sativus (Radish) Seed Oil, Diethylhexyl syringylidenemalonate, Helianthuus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Chlorphenesin, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Argania Spinosa Kernel Oil, Caprylic/Capric Triglyceride, Citrus Nobilis (Madarin Orange) Peel Oil, Plantago Lanceolata Leaf Extract, Glycine Soja (Soybean) Oil, Tocopherol, Cymbopogon Schoenanthus Oil, Hippophae Rhamnoides Fruit Oil, Elettaria Cardamomum Seed Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Cinnamomum Cassia Leaf Oil, Vanillin, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Grosso Herb Oil

Section 51945-4

Supergoop!

Handscreen SPF 40

Broad Spectrum Sunscreen SPF 40

1.0fl. oz./ 30 ml.

Section 55105-1

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.

Section 55106-9

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

Directions

  • Apply generously and evenly 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply 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 value of 15 or higher and other sun
  • protection measures including: • limit your 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.
Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Propanediol, Glyceryl Stearate Citrate, Cocoglycerides, Isododecane, Cetyl Esters, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Arginine, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Polymethylsilsequioxane, Raphanus Sativus (Radish) Seed Oil, Diethylhexyl syringylidenemalonate, Helianthuus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Chlorphenesin, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Argania Spinosa Kernel Oil, Caprylic/Capric Triglyceride, Citrus Nobilis (Madarin Orange) Peel Oil, Plantago Lanceolata Leaf Extract, Glycine Soja (Soybean) Oil, Tocopherol, Cymbopogon Schoenanthus Oil, Hippophae Rhamnoides Fruit Oil, Elettaria Cardamomum Seed Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Cinnamomum Cassia Leaf Oil, Vanillin, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Grosso Herb Oil

Section 51945-4 (51945-4)

Supergoop!

Handscreen SPF 40

Broad Spectrum Sunscreen SPF 40

1.0fl. oz./ 30 ml.

Section 55105-1 (55105-1)

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.

Section 55106-9 (55106-9)

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen


Advanced Ingredient Data


Raw Label Data

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