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

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.

Active Ingredient

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.

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

Description

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

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


Structured Label Content

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.

Active Ingredient (55106-9)

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.

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)