Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 9dbe250b-1b88-43b7-8e24-c1f5aaba0f8d
Route
TOPICAL
Published
Effective Date 2022-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octisalate (5 g) Zinc Oxide (21.3 g)
Inactive Ingredients
Water Squalane Isoeicosane Dimethicone Glycerin Cetyl Dimethicone 25 Argania Spinosa Leaf Silicon Dioxide Sorbitan Sesquioleate .alpha.-tocopherol Acetate Triethoxycaprylylsilane Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Isohexadecane Polysorbate 60 Phenoxyethanol Caprylyl Glycol Hexylene Glycol Ethylhexylglycerin Bisabolol Oxide A Matricaria Chamomilla Citric Acid Monohydrate Tetrahexyldecyl Ascorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-11

Description

Avobenzone 3% Octisalate 5% Zinc Oxide 4%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Octisalate 5% Zinc Oxide 4%

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

Warnings

For external use only



Do not use on damaged or broken skin



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



Stop use and ask a docor if rash occurs



Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• use a water-resistant sunscreen if swimming or sweating

• reapply at least every two hours•Sun Protection Measures. Spending time in the sunincreases your risk of skin cancer and early skin aging. To decreasethis risk, regularly use a sunscreen with a Broad Spectrum SPFvalue 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

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Avobenzone 3%

Octisalate 5%

Zinc Oxide 4%

Inactive Ingredients

Water, Squalane, Isoeicosane, Dimethicone,

Glycerin, Cetyl Dimethicone,

Argania Spinosa Kernel Oil,

Silica, Sorbitan Sesquioleate, Tocopheryl

Acetate, Triethoxycaprylylsilane,

Hydroxyethyl Acrylate/Sodium

Acryloyldimethyl Taurate Copolymer,

Isohexadecane, Polysorbate 60,

Phenoxyethanol, Caprylyl Glycol,

Hexylene Glycol, Ethylhexylglycerin,

Bisabolol, Chamomilla Recutita

(Matricaria) Flower Extract, Citric

Acid, Tetrahexyldecyl Ascorbate.

May Contain (+/-): Titanium Dioxide,

Iron Oxides

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children


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 aging caused by the sun

Purpose

Sunscreen

Warnings

For external use only



Do not use on damaged or broken skin



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



Stop use and ask a docor if rash occurs



Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• use a water-resistant sunscreen if swimming or sweating

• reapply at least every two hours•Sun Protection Measures. Spending time in the sunincreases your risk of skin cancer and early skin aging. To decreasethis risk, regularly use a sunscreen with a Broad Spectrum SPFvalue 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

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Avobenzone 3%

Octisalate 5%

Zinc Oxide 4%

Inactive Ingredients (Inactive ingredients)

Water, Squalane, Isoeicosane, Dimethicone,

Glycerin, Cetyl Dimethicone,

Argania Spinosa Kernel Oil,

Silica, Sorbitan Sesquioleate, Tocopheryl

Acetate, Triethoxycaprylylsilane,

Hydroxyethyl Acrylate/Sodium

Acryloyldimethyl Taurate Copolymer,

Isohexadecane, Polysorbate 60,

Phenoxyethanol, Caprylyl Glycol,

Hexylene Glycol, Ethylhexylglycerin,

Bisabolol, Chamomilla Recutita

(Matricaria) Flower Extract, Citric

Acid, Tetrahexyldecyl Ascorbate.

May Contain (+/-): Titanium Dioxide,

Iron Oxides

Principal Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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