83447-003

83447-003
SPL v3
SPL
SPL Set ID 0808b0cd-2cfb-8554-e063-6294a90ad6c4
Route
CUTANEOUS
Published
Effective Date 2023-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (8 g) Homosalate (10 g) Octisalate (5 g) Avobenzone (3 g)
Inactive Ingredients
Hyaluronic Acid .alpha.-tocopherol Acetate Kakadu Plum Butyloctyl Salicylate Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Water Ethyl Acrylate And Methyl Methacrylate Copolymer (2:1; 750000 Mw) Alcohol Levomenol Dicaprylyl Ether Diheptyl Succinate Ethyl Ferulate Isononyl Isononanoate Pelargonium Graveolens Flower Oil Docusate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-19

Description

Homosalate 10% Octocrylene 8% Octilsalate 5% Avobenzone 3%


Medication Information

Description

Homosalate 10% Octocrylene 8% Octilsalate 5% Avobenzone 3%

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures ( see directions ), decreases the risk of skin cancer and early skin ageing caused by the sun.

Section 50565-1

Keep out of reach of children

Section 50570-1

Do not use on damaged or broken skin

Section 51945-4

Section 55105-1

sunscreen

Section 55106-9

Homosalate 10%

Octocrylene 8%

Octilsalate 5%

Avobenzone 3%

Warnings

For external use only.

Avoid contact with eyes , wear protective clothing , hats and eyewear when exposed to the sun . Avoid prolonged exposure in the sun.

Keep out of reach of children.

Do not use on damaged or brokenskin.

Store in a cool , dry place and avoiddirect sunlight.

If using with other sun protection products , consult with a doctor before use.

Directions

Shake the spray bottle well before use.

Hold the spray bottle at an appropriate distance from the face and neck . Spray evenly onto the entire face and neck area.

Avoid direct contact with eves . In case of eye contact , rinse immediately with water.

For continued sun protection , reapply every 2 hours

Other Information

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

Inactive Ingredients

Auqa , Methacrylate Copolymer , Alcohol Denat , Bisabolol , Hvaluronic Acid, D-alpha-tocopheryl acetate , Terminalia Ferdinandiana , Butyloctyl Salicylate, Sebacic Acid Copolymer , Dicaprylyl Ether , Diheptyl Succinate , Diisooctyl Succinate , Ethyl Ferulat , Isononyl sononanoate , Pelargonium Graveolens Flower Oil


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 ageing caused by the sun.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

sunscreen

Section 55106-9 (55106-9)

Homosalate 10%

Octocrylene 8%

Octilsalate 5%

Avobenzone 3%

Warnings

For external use only.

Avoid contact with eyes , wear protective clothing , hats and eyewear when exposed to the sun . Avoid prolonged exposure in the sun.

Keep out of reach of children.

Do not use on damaged or brokenskin.

Store in a cool , dry place and avoiddirect sunlight.

If using with other sun protection products , consult with a doctor before use.

Directions

Shake the spray bottle well before use.

Hold the spray bottle at an appropriate distance from the face and neck . Spray evenly onto the entire face and neck area.

Avoid direct contact with eves . In case of eye contact , rinse immediately with water.

For continued sun protection , reapply every 2 hours

Other Information (Other information)

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

Inactive Ingredients

Auqa , Methacrylate Copolymer , Alcohol Denat , Bisabolol , Hvaluronic Acid, D-alpha-tocopheryl acetate , Terminalia Ferdinandiana , Butyloctyl Salicylate, Sebacic Acid Copolymer , Dicaprylyl Ether , Diheptyl Succinate , Diisooctyl Succinate , Ethyl Ferulat , Isononyl sononanoate , Pelargonium Graveolens Flower Oil


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)