SPL v4
SPL
SPL Set ID 0439b4b6-2792-3af1-e063-6294a90adcfe
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
Diisopropyl Adipate Polyglyceryl-3 Methylglucose Distearate Glyceryl Monostearate Edetate Disodium Papaya Passiflora Incarnata Fruit Caprylyl Glycol Chlorphenesin Sodium Polyacrylate (2500000 Mw) Hyaluronate Sodium Guava Plumeria Rubra Flower Water Starch, Rice Phenoxyethanol Peg-100 Stearate Aloe Vera Leaf Butylene Glycol Mango Glycerin Butyloctyl Salicylate

Identifiers & Packaging

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

Description

Avobenzone 2.7%, Homosalate 8.0%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

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

Warnings

For external use only

Directions

• Shake well • Hold container 4 to 6 inches from the skin to apply • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands and then apply to face. • Do not apply in windy conditions • Use in a well-ventilated area • 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.

Active Ingredient

Avobenzone 2.7%, Homosalate 8.0%, Octocrylene 6.0%

Other Information

Protect this product from excessive heat and direct sun

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, Sodium Polyacrylate, Glycerin, Aloe Barbadensis Leaf Juice Powder, Disodium EDTA, Sodium Hyaluronate, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract.

Questions Or Comments?

1-800-NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN TROPIC

WATER SUNSCREEN MIST

WEIGHTLESS

HYDRATION

12 HR MOISTURIZATION

HYALURONIC ACID

30

ALCOHOL FREE

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

5. Fl. OZ (153 ml)

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.


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

Directions

• Shake well • Hold container 4 to 6 inches from the skin to apply • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands and then apply to face. • Do not apply in windy conditions • Use in a well-ventilated area • 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.

Active Ingredient

Avobenzone 2.7%, Homosalate 8.0%, Octocrylene 6.0%

Other Information

Protect this product from excessive heat and direct sun

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, Sodium Polyacrylate, Glycerin, Aloe Barbadensis Leaf Juice Powder, Disodium EDTA, Sodium Hyaluronate, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract.

Questions Or Comments? (Questions or Comments?)

1-800-NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN TROPIC

WATER SUNSCREEN MIST

WEIGHTLESS

HYDRATION

12 HR MOISTURIZATION

HYALURONIC ACID

30

ALCOHOL FREE

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

5. Fl. OZ (153 ml)

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.


Advanced Ingredient Data


Raw Label Data

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