Abib

Abib
SPL v3
SPL
SPL Set ID 1a2ab632-643f-1aa9-e063-6394a90a0c05
Route
TOPICAL
Published
Effective Date 2024-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octocrylene (5 g) Homosalate (9.5 g) Octisalate (4.5 g)
Inactive Ingredients
Maltodextrin Butylene Glycol Propanediol Prezatide Copper Butyloctyl Salicylate Acetyl Hexapeptide-8 Water Olive Oil Methyl Rapeseedate Hyaluronate Sodium 1,2-hexanediol Hydrogenated Soybean Lecithin Butylene Glycol Dicaprylate/dicaprate Diisostearyl Malate Dibutyl Ethylhexanoyl Glutamide Glycerin Tocopherol Dibutyl Lauroyl Glutamide Squalane Medium-chain Triglycerides Alkyl (c12-15) Benzoate Caprylyl Glycol Dextrin Palmitate (corn; 20000 Mw) Argan Oil Green Tea Leaf Octyldodecanol Tamanu Oil Ceramide Np Aloe Vera Leaf Centella Asiatica Hydrolyzed Senegalia Macrostachya Seed Protein (enzymatic; 800 Mw) Starmarella Bombicola Anhydrous Dextrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-05

Description

Active ingredients Homosalate 9.50%, Octocrylene 5.00%, Octisalate 4.50%, Avobenzone 3.00%


Medication Information

Warnings and Precautions

Warnings For external use only.

Indications and Usage

Uses

  • help prevent sunburn
  • if used as directed with other sun protection measures ( see Directions), deacreases the risk of skin cancer and early skin aging caused by the sun
Dosage and Administration

Directions apply liberally and evenly 15 minutes before sun exposure. reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours. children under 6 months of age: ask a doctor. Sun protection measures. spending time in the sun increases your risk of skin cancer and early 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

Description

Active ingredients Homosalate 9.50%, Octocrylene 5.00%, Octisalate 4.50%, Avobenzone 3.00%

Section 42229-5

Other information: protect this product from excessive heat and direct sun. may stain some fabrics. protect from freezing

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Actives ingredients Octyldodecanol, Butylene Glycol Dicaprylate/Dicaprate, Dibutyl Lauroyl Glutamide, Diisostearyl Malate, Dibutyl Ethylhexanoyl Glutamide, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Dextrin Palmitate, Water, Sodium Hyaluronate, Squalane, Calophyllum Inophyllum Seed Oil, Argania Spinosa Kegnel Oil, Olea Euro paea (Olive) Fruit Oil, Glycerin, Aloe Barbadensis Leaf Extract, Hydrolyzed Vegetable Protein, Maltodextrin, Butylene Glycol, Propanediol, Caprylic/Capric Trigly ceride, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Hydrogenated Lecithin, Centella Asiatica Extract, Candida Bombicola/Glucose/Methyl Rapeseedate Fer ment, Ceramide NP, Caprylyl Glycol, Tocopherol, Acetyl Hexapeptide-8, Copper Tripeptide-1

Section 51945-4

Abib

Quick sunstick

Protection bar

Broad Spectrum SPF 50+

NET WT. 0.77 OZ. 22g

Section 55105-1

Purpose sunscreen

Section 55106-9

Active ingredients

Homosalate 9.50%, Octocrylene 5.00%, Octisalate 4.50%, Avobenzone 3.00%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • help prevent sunburn
  • if used as directed with other sun protection measures ( see Directions), deacreases the risk of skin cancer and early skin aging caused by the sun
Dosage and Administration (34068-7)

Directions apply liberally and evenly 15 minutes before sun exposure. reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours. children under 6 months of age: ask a doctor. Sun protection measures. spending time in the sun increases your risk of skin cancer and early 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

Warnings and Precautions (34071-1)

Warnings For external use only.

Section 42229-5 (42229-5)

Other information: protect this product from excessive heat and direct sun. may stain some fabrics. protect from freezing

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Actives ingredients Octyldodecanol, Butylene Glycol Dicaprylate/Dicaprate, Dibutyl Lauroyl Glutamide, Diisostearyl Malate, Dibutyl Ethylhexanoyl Glutamide, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Dextrin Palmitate, Water, Sodium Hyaluronate, Squalane, Calophyllum Inophyllum Seed Oil, Argania Spinosa Kegnel Oil, Olea Euro paea (Olive) Fruit Oil, Glycerin, Aloe Barbadensis Leaf Extract, Hydrolyzed Vegetable Protein, Maltodextrin, Butylene Glycol, Propanediol, Caprylic/Capric Trigly ceride, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Hydrogenated Lecithin, Centella Asiatica Extract, Candida Bombicola/Glucose/Methyl Rapeseedate Fer ment, Ceramide NP, Caprylyl Glycol, Tocopherol, Acetyl Hexapeptide-8, Copper Tripeptide-1

Section 51945-4 (51945-4)

Abib

Quick sunstick

Protection bar

Broad Spectrum SPF 50+

NET WT. 0.77 OZ. 22g

Section 55105-1 (55105-1)

Purpose sunscreen

Section 55106-9 (55106-9)

Active ingredients

Homosalate 9.50%, Octocrylene 5.00%, Octisalate 4.50%, Avobenzone 3.00%


Advanced Ingredient Data


Raw Label Data

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