SPL v5
SPL
SPL Set ID 051b7413-8f1b-7135-e063-6294a90a9364
Route
TOPICAL
Published
Effective Date 2023-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (8 g) Octocrylene (6 g) Avobenzone (2.7 g)
Inactive Ingredients
Aloe Vera Leaf Butyloctyl Salicylate Hyaluronate Sodium Sodium Polyacrylate (2500000 Mw) Chlorphenesin Glycerin Butylene Glycol Passiflora Incarnata Fruit Glyceryl Monostearate Peg-100 Stearate Guava Edetate Disodium Hibiscus Sabdariffa Flower Mango Plumeria Rubra Flower Water Diisopropyl Adipate Polyglyceryl-3 Methylglucose Distearate Starch, Rice Caprylyl Glycol Papaya Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

Avobenzone 2.7% Homosalate 8.0% Octocrylene 6.0%

Purpose

​Sunscreen Agent


Medication Information

Purpose

​Sunscreen Agent

Description

Avobenzone 2.7% Homosalate 8.0% Octocrylene 6.0%

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

Section 51945-4

HAWAIIAN TROPIC

WATER SUNSCREEN MIST

WEIGHTLESS

HYDRATION

12 HR MOISTURIZATION

HYALURONIC ACID

FACE

30

ALCOHOL FREE

DERM TESTED | VEGAN

BROAD SPECTRUM

SPF 30 UVA/UVB

2.1 FL. OZ (62 ml)

HAWAIIAN TROPIC

WATER SUNSCREEN MIST

WEIGHTLESS

HYDRATION

12 HR MOISTURIZATION

HYALURONIC ACID

FACE

30

ALCOHOL FREE

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

2.1 FL. OZ (62 ml)

Warnings

• For external use only

Directions

• Shake well • Hold container 4 to 6 inches from the skin to apply. Don’t spray directly into face. Apply on hand then apply to face. Spray evenly and liberally on your skin. Apply 15 minutes before sun exposure. Reapply throughout the day • at least every 2 hours, • after 80 minutes of swimming orsweating • immediately after towel drying • 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 2.7% Homosalate 8.0% Octocrylene 6.0%

Inactive Ingredients

Water, Diisopropyl Adipate, Butyloctyl Salicylate, Butylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Oryza Sativa (Rice) Starch, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Chlorphenesin, PEG-100 Stearate, Glyceryl Stearate, Fragrance, Glycerin, Sodium Polyacrylate, Aloe Barbadensis Leaf Juice Powder, Disodium EDTA, Sodium Hyaluronate, Hibiscus Sabdariffa Flower Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract.

Questions Or Comments?

1-800-NO UV RAY, Mon-Fri

When Using This Product

Keep away from face to avoid breathing it • 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. May stain some fabrics and surfaces.


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

Section 51945-4 (51945-4)

HAWAIIAN TROPIC

WATER SUNSCREEN MIST

WEIGHTLESS

HYDRATION

12 HR MOISTURIZATION

HYALURONIC ACID

FACE

30

ALCOHOL FREE

DERM TESTED | VEGAN

BROAD SPECTRUM

SPF 30 UVA/UVB

2.1 FL. OZ (62 ml)

HAWAIIAN TROPIC

WATER SUNSCREEN MIST

WEIGHTLESS

HYDRATION

12 HR MOISTURIZATION

HYALURONIC ACID

FACE

30

ALCOHOL FREE

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

2.1 FL. OZ (62 ml)

Purpose

​Sunscreen Agent

Warnings

• For external use only

Directions

• Shake well • Hold container 4 to 6 inches from the skin to apply. Don’t spray directly into face. Apply on hand then apply to face. Spray evenly and liberally on your skin. Apply 15 minutes before sun exposure. Reapply throughout the day • at least every 2 hours, • after 80 minutes of swimming orsweating • immediately after towel drying • 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

• protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7% Homosalate 8.0% Octocrylene 6.0%

Inactive Ingredients

Water, Diisopropyl Adipate, Butyloctyl Salicylate, Butylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Oryza Sativa (Rice) Starch, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Chlorphenesin, PEG-100 Stearate, Glyceryl Stearate, Fragrance, Glycerin, Sodium Polyacrylate, Aloe Barbadensis Leaf Juice Powder, Disodium EDTA, Sodium Hyaluronate, Hibiscus Sabdariffa Flower Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract.

Questions Or Comments? (Questions or Comments?)

1-800-NO UV RAY, Mon-Fri

When Using This Product (When using this product)

Keep away from face to avoid breathing it • 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. May stain some fabrics and surfaces.


Advanced Ingredient Data


Raw Label Data

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