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SPL v1
SPL
SPL Set ID 4260e410-d2d5-71b4-e063-6294a90a05b8
Route
topical
Published
Effective Date 2024-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (13.5 g) octisalate (4.5 g) avobenzone (2.7 g)
Inactive Ingredients
benzotriazolyl dodecyl p-cresol biosaccharide gum-1 tromethamine hyaluronate sodium glyceryl stearate citrate chamaemelum nobile flower oil glyceryl polymethacrylate (300000 mpa.s) triethoxycaprylylsilane tocopherol hyaluronic acid sparassis crispa fruiting body purslane water butyloctyl salicylate propanediol butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) butylene glycol caprylyl trisiloxane polyglyceryl-3 distearate diethylhexyl 2,6-naphthalate niacinamide polymethylsilsesquioxane (4.5 microns) glycerin pine needle oil (pinus sylvestris) calcium aluminum borosilicate 1,2-hexanediol behenyl acrylate polymer pentylene glycol cetostearyl alcohol methylpropanediol betula platyphylla var. japonica resin acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s) carbomer homopolymer, unspecified type ethylhexylglycerin artemisia annua leaf sodium stearoyl glutamate dipropylene glycol allantoin glyceryl glucoside ascorbic acid polyether-1 (2800 mpa.s)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-18

Purpose

Sunscreen

Description

Avobenzone 2.7% Homosalate 13.5% Octisalate 4.5%


Medication Information

Warnings

For external use only.

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.

Purpose

Sunscreen

Directions
  • apply liberally and evenly 15 minutes before sun exposure.
  • 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

  • children under 6 months of age: Ask a doctor
  • reapply at least every 2 hours.
  • use a water-resistant sunscreen if swimming or sweating
Other Information

protect the product from excessive heat and direct sun

Inactive Ingredients

Water, Butyloctyl Salicylate, Propanediol, Acrylates Copolymer, Butylene Glycol, Caprylyl Methicone, Polyglyceryl-3 Distearate, Benzotriazolyl Dodecyl P-Cresol, Niacinamide, Diethylhexyl 2,6-Naphthalate, Polymethylsisesquioxane, Glycerin, Calcium Aluminum Borosilicate, 1,2-Hexanediol, Poly C10-30 Alkyl Acrylate, Pentylene Glycol, Cetearyl Aloohol, Tromethamine, Methy propanediol, Glyceryl Stearate Citrate, Betula Platyphylla Japonica Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Ethylhexylglycerin, Artemisia Annua Extract, Anthemis Nobilis Flower Oil, Sodium Stearoyl Glutamate, Glyceryl Polymethacrylate, Triethoxycaprylylsilane, Pinus Sylvestris Leaf Oil, Sparassis Crispa Extract, Polyether-1, Allantoin, Di-propylene Glycol, Glyceryl Glucoside, Biosaccharide Gum-1, Tocopherol, Portulaca Oleracea Extract, Sodium Hyaluronate, Hyaluronic Acid, Ascorbic Acid

Description

Avobenzone 2.7% Homosalate 13.5% Octisalate 4.5%

Section 50565-1

Keep out of reach of children.

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

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 51945-4

Round Lab

Birch Juice

Moisturizing UVLOCK

Sunscreen

SPF45 Broad Spectrum

50 mL 1.69 fl. oz.

Actives Ingredients

Avobenzone 2.7%

Homosalate 13.5%

Octisalate 4.5%

Questions Or Comments?

www.roundlab.com


Structured Label Content

Warnings

For external use only.

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.

Purpose

Sunscreen

Directions
  • apply liberally and evenly 15 minutes before sun exposure.
  • 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

  • children under 6 months of age: Ask a doctor
  • reapply at least every 2 hours.
  • use a water-resistant sunscreen if swimming or sweating
Other Information

protect the product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Butyloctyl Salicylate, Propanediol, Acrylates Copolymer, Butylene Glycol, Caprylyl Methicone, Polyglyceryl-3 Distearate, Benzotriazolyl Dodecyl P-Cresol, Niacinamide, Diethylhexyl 2,6-Naphthalate, Polymethylsisesquioxane, Glycerin, Calcium Aluminum Borosilicate, 1,2-Hexanediol, Poly C10-30 Alkyl Acrylate, Pentylene Glycol, Cetearyl Aloohol, Tromethamine, Methy propanediol, Glyceryl Stearate Citrate, Betula Platyphylla Japonica Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Ethylhexylglycerin, Artemisia Annua Extract, Anthemis Nobilis Flower Oil, Sodium Stearoyl Glutamate, Glyceryl Polymethacrylate, Triethoxycaprylylsilane, Pinus Sylvestris Leaf Oil, Sparassis Crispa Extract, Polyether-1, Allantoin, Di-propylene Glycol, Glyceryl Glucoside, Biosaccharide Gum-1, Tocopherol, Portulaca Oleracea Extract, Sodium Hyaluronate, Hyaluronic Acid, Ascorbic Acid

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 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 51945-4 (51945-4)

Round Lab

Birch Juice

Moisturizing UVLOCK

Sunscreen

SPF45 Broad Spectrum

50 mL 1.69 fl. oz.

Actives Ingredients

Avobenzone 2.7%

Homosalate 13.5%

Octisalate 4.5%

Questions Or Comments? (Questions or comments?)

www.roundlab.com


Advanced Ingredient Data


Raw Label Data

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