drug facts

drug facts
SPL v1
SPL
SPL Set ID cca5d399-5017-4b8d-8a19-3f6370664c18
Route
topical
Published
Effective Date 2017-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) octinoxate (7.5 g) octisalate (5 g)
Inactive Ingredients
water octyldodecyl neopentanoate butylene glycol mica titanium dioxide glycerin simmondsia chinensis seed shea butter stearic acid behenyl benzoate glyceryl stearate se myristyl alcohol lauryl alcohol cetyl alcohol palmitic acid coco glucoside .alpha.-tocopherol acetate tetrahexyldecyl ascorbate prunus armeniaca leaf carica papaya leaf cymbopogon schoenanthus oil aesculus hippocastanum leaf aloe vera leaf polysorbate 20 sorbitan olivate propylene glycol stearate carbomer 940 sodium hydride propylene glycol laurates ethylhexylglycerin disodium edta-copper phenoxyethanol o-cymen-5-ol benzyl alcohol benzyl salicylate butylphenyl methylpropional

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-01-18

Description

Avobenzone 3.00% Octinoxate 7.50% Octisalate 5.0%


Medication Information

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 docor if rash occurs
  • Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure
  • Use water resistant sunscreen if swimming or sweathing
  • Reapply at least every 2 hours
  • Children under 6 months: ask a doctor
  • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
Other Information

Protect this product form excessive heat and direct sun

Inactive Ingredients

Water (Aqua, Eau), Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Butylene Glycol, Mica, Titanium Dioxide (CI 77891), Glycerin, Simmondsia Chinensis Seed Oil, Butyrospermum Parkii (Shea) Butter, Hexapeptide-33, Stearic Acid, Behenyl Alcohol, Glyceryl Stearate, Lecithin,Myristyl Alcohol, Lauryl Alcohol, Cetyl Alcohol, Palmitic Acid, Cetearyl Alcohol, Coco-Glucoside, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Prunus Armeniaca Kernel Oil, Carica Papaya Fruit Extract, Cymbopogon Schoenanthus Extract, Aesculus Hippocastanum Seed Extract, Aloe Barbadensis Leaf Extract, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Sodium Hydroxide, Propylene Glycol Laurate, Ethylhexylglycerin, Disodium Edta, Phenoxyethanol, o-Cymen-5-Ol, Fragrance (Parfum), Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, d-Limonene

Description

Avobenzone 3.00% Octinoxate 7.50% Octisalate 5.0%

Principal Display Panel

Use

Helps prevent sunburn. If used as directed with other sun protection measures, helps decrease the risk of skin cancer and early signs of aging caused by the sun.

Active Ingredients

Avobenzone 3.00%

Octinoxate 7.50%

Octisalate 5.0%


Structured Label Content

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 docor if rash occurs
  • Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure
  • Use water resistant sunscreen if swimming or sweathing
  • Reapply at least every 2 hours
  • Children under 6 months: ask a doctor
  • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
Other Information

Protect this product form excessive heat and direct sun

Inactive Ingredients

Water (Aqua, Eau), Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Butylene Glycol, Mica, Titanium Dioxide (CI 77891), Glycerin, Simmondsia Chinensis Seed Oil, Butyrospermum Parkii (Shea) Butter, Hexapeptide-33, Stearic Acid, Behenyl Alcohol, Glyceryl Stearate, Lecithin,Myristyl Alcohol, Lauryl Alcohol, Cetyl Alcohol, Palmitic Acid, Cetearyl Alcohol, Coco-Glucoside, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Prunus Armeniaca Kernel Oil, Carica Papaya Fruit Extract, Cymbopogon Schoenanthus Extract, Aesculus Hippocastanum Seed Extract, Aloe Barbadensis Leaf Extract, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Sodium Hydroxide, Propylene Glycol Laurate, Ethylhexylglycerin, Disodium Edta, Phenoxyethanol, o-Cymen-5-Ol, Fragrance (Parfum), Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, d-Limonene

Principal Display Panel

Use

Helps prevent sunburn. If used as directed with other sun protection measures, helps decrease the risk of skin cancer and early signs of aging caused by the sun.

Active Ingredients

Avobenzone 3.00%

Octinoxate 7.50%

Octisalate 5.0%


Advanced Ingredient Data


Raw Label Data

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