84356-001

84356-001
SPL v2
SPL
SPL Set ID 19a3687b-32b0-7c83-e063-6294a90aaf81
Route
TOPICAL
Published
Effective Date 2024-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octisalate (5 g) Homosalate (10 g) Octocrylene (8 g)
Inactive Ingredients
Kakadu Plum Ammonio Methacrylate Copolymer Type A Water Alcohol Levomenol Hyaluronic Acid .alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-30

Description

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

Purpose

sunscreen


Medication Information

Purpose

sunscreen

Description

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

Use

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. If swallowed, get medical help or contact a Poison

Control C enter right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a

serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with

eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or

rash occurs. These may be signs of a serious condition. Keep out of reach of

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

Directions

DIRECTION:

1.Shake the spray bottle well before use.

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

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

4.For continued sun protection, reapply every 2 hours.

Do Not Use

in children less than 2 months of age on open skin wounds.

Other Information
  • Protect the product in this container from excessive heat and direct sun.

Active Ingredient(s)

Avobenzone 3%

Homosalate 10%

Octocrylene 8%

Octilsalate 5%

Inactive Ingredients

INACTIVE INGREDIENTS:

Auqa, Methacrylate Copolymer, Alcohol Denat, Bisabolol, Hyaluronic Acid,

D- Alpha-tocopheryl acetate, Terminalia Ferdinandiana, Butyloctyl Salicylate,

Sebacic Acid Copolymer, Dicaprylyl Ether, Diheptyl Succinate, Disooctyl Succinate,

Ethyl Ferulat, IsononyI Isononanoate, Pelargonium Graveolens Flower Oil.

Package Label Principal Display Panel


Structured Label Content

Use

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. If swallowed, get medical help or contact a Poison

Control C enter right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a

serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with

eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or

rash occurs. These may be signs of a serious condition. Keep out of reach of

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

Purpose

sunscreen

Directions

DIRECTION:

1.Shake the spray bottle well before use.

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

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

4.For continued sun protection, reapply every 2 hours.

Do Not Use (Do not use)

in children less than 2 months of age on open skin wounds.

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.

Active Ingredient(s)

Avobenzone 3%

Homosalate 10%

Octocrylene 8%

Octilsalate 5%

Inactive Ingredients (Inactive ingredients)

INACTIVE INGREDIENTS:

Auqa, Methacrylate Copolymer, Alcohol Denat, Bisabolol, Hyaluronic Acid,

D- Alpha-tocopheryl acetate, Terminalia Ferdinandiana, Butyloctyl Salicylate,

Sebacic Acid Copolymer, Dicaprylyl Ether, Diheptyl Succinate, Disooctyl Succinate,

Ethyl Ferulat, IsononyI Isononanoate, Pelargonium Graveolens Flower Oil.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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