SPL v5
SPL
SPL Set ID b1cc98e5-ab2c-6af1-e053-2a95a90a50a2
Route
TOPICAL
Published
Effective Date 2020-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (4.5 g) Avobenzone (2 g) Homosalate (5.5 g) Octocrylene (4 g)
Inactive Ingredients
Dihexadecyl Phosphate Sodium Ascorbyl Phosphate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Butylene Glycol Polysorbate 60 Benzyl Alcohol Isohexadecane Caprylyl Glycol Chlorphenesin Diisopropyl Adipate .alpha.-tocopherol Acetate Panthenol Papaya Xanthan Gum Aminomethylpropanol Mica Ferric Oxide Yellow Mango Guava Ceteth-10 Phosphate Edetate Disodium Anhydrous Coco Glucoside Cetostearyl Alcohol Phenoxyethanol Passiflora Incarnata Fruit Titanium Dioxide Aloe Vera Leaf Amino Acids, Silk Plumeria Rubra Flower Alkyl (c12-15) Benzoate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-23

Description

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

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.

May stain some fabrics.

Directions

• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin 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: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Diisopropyl Adipate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene Glycol, Cetearyl Alcohol, Acrylates/C12-22Alkyl Methacrylate Copolymer, Phenoxyethanol, Isohexadecane, Caprylyl Glycol, Benzyl Alcohol, Fragrance, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Polysorbate 60, Xanthan Gum, Coco-Glucoside, Disodium EDTA, Aminomethyl Propanol, Mica, Tocopheryl Acetate, Titanium Dioxide, Panthenol, Aloe Barbadensis Leaf Juice, Silk Amino Acids, Sodium Ascorbyl Phosphate, Psidium Guajava Fruit, Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Iron Oxides

Primary Display Panel

HAWAIIAN

TROPIC

SUNSCREEN LOTION

WEIGHTLESS

HYDRATION

12 HR MOISTURIZATION*

ISLAND BOTANICALS

30

DERM TESTED

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

6 FL. OZ. (177mL)

Questions Or Comments?

Call 1-800-NO UV RAY, Mon-Fri

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children

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


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.

May stain some fabrics.

Directions

• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin 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: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Inactive Ingredients (Inactive ingredients)

Water, C12-15 Alkyl Benzoate, Diisopropyl Adipate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene Glycol, Cetearyl Alcohol, Acrylates/C12-22Alkyl Methacrylate Copolymer, Phenoxyethanol, Isohexadecane, Caprylyl Glycol, Benzyl Alcohol, Fragrance, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Polysorbate 60, Xanthan Gum, Coco-Glucoside, Disodium EDTA, Aminomethyl Propanol, Mica, Tocopheryl Acetate, Titanium Dioxide, Panthenol, Aloe Barbadensis Leaf Juice, Silk Amino Acids, Sodium Ascorbyl Phosphate, Psidium Guajava Fruit, Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Iron Oxides

Primary Display Panel

HAWAIIAN

TROPIC

SUNSCREEN LOTION

WEIGHTLESS

HYDRATION

12 HR MOISTURIZATION*

ISLAND BOTANICALS

30

DERM TESTED

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

6 FL. OZ. (177mL)

Questions Or Comments? (Questions or Comments?)

Call 1-800-NO UV RAY, Mon-Fri

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

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

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


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