Image Prevention Refiner Primer Spf50

Image Prevention Refiner Primer Spf50
SPL v3
SPL
SPL Set ID 0e490f11-666c-420c-8c12-b45cd238ce47
Route
TOPICAL
Published
Effective Date 2023-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (210 g) Titanium Dioxide (50 g)
Inactive Ingredients
Isododecane Butyloctyl Salicylate Octyldodecyl Neopentanoate Propylene Carbonate Dimethicone Stearalkonium Hectorite Glycerin Polyhydroxystearic Acid (2300 Mw) Isostearic Acid Lecithin, Soybean Water Limonene, (+)- .alpha.-tocopherol Acetate Tetrahexyldecyl Ascorbate Sodium Chloride Gluconolactone Sodium Benzoate Calcium Gluconate Medium-chain Triglycerides Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Silicon Dioxide Hydrogenated Polybutene (1300 Mw) Sunflower Oil Orange Oil Gossypium Hirsutum Whole Anhydrous Dextrose Agathosma Betulina Leaf Oil Vanilla Bean Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-06

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 doctor if rash occurs. If 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 doctor if rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.

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.

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 doctor if rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

Questions Call 800-796-7546

Directions

Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Immediately after towel drying. At least every 2 hours. Use a water resistant sunscreen when swimming or sweating, immediately after towel drying, at least every two 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 time in the sun, especially from 10am to 2pm, wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

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

Active Ingredients

Zinc Oxide 21%   Sunscreen

Titanium Dioxide 5%   Sunscreen

Inactive Ingredients

idododecane, caprylic/capric triglyceride, butyloctyl salicylate, octyldodecyl neopentanoate, adipic acid/neopentyl glycol crosspolymer, lauryl dimethicone, polysilicone-11, propylene carbonate, silica cetyl silylate, dimethicone, stearalkonium hectorite, glycerin, polyhydroxystearic acid, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, hydrogenated polyisobutene, polyglyceryl-4 diisotearate/polyhydroxystearate/sebacate, silica, water, helinathus annuus (sunflower) seed oil, citrus aurantium dulcis (orange) peel oil, limonene, tocopheryl acetate, gossypium hirsuthum (cotton) extract, tetrahexyldecyl ascorbate, glucose, hydrolyzed pea protein, sodium chloride, glyconolactone, barosma betulina leaf oil, vanilla planifolia fruit extract, sodium benzoate, sodium succinate, calcium glyconate, iron oxides (CI77492, CI77491, CI77499)

Keep Out of Reach of Children

Keep out of Reach of Children


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.

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 doctor if rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

Questions Call 800-796-7546

Directions

Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Immediately after towel drying. At least every 2 hours. Use a water resistant sunscreen when swimming or sweating, immediately after towel drying, at least every two 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 time in the sun, especially from 10am to 2pm, wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

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

Active Ingredients

Zinc Oxide 21%   Sunscreen

Titanium Dioxide 5%   Sunscreen

Inactive Ingredients

idododecane, caprylic/capric triglyceride, butyloctyl salicylate, octyldodecyl neopentanoate, adipic acid/neopentyl glycol crosspolymer, lauryl dimethicone, polysilicone-11, propylene carbonate, silica cetyl silylate, dimethicone, stearalkonium hectorite, glycerin, polyhydroxystearic acid, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, hydrogenated polyisobutene, polyglyceryl-4 diisotearate/polyhydroxystearate/sebacate, silica, water, helinathus annuus (sunflower) seed oil, citrus aurantium dulcis (orange) peel oil, limonene, tocopheryl acetate, gossypium hirsuthum (cotton) extract, tetrahexyldecyl ascorbate, glucose, hydrolyzed pea protein, sodium chloride, glyconolactone, barosma betulina leaf oil, vanilla planifolia fruit extract, sodium benzoate, sodium succinate, calcium glyconate, iron oxides (CI77492, CI77491, CI77499)

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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