Naked Sundays Cabana Creme Hydrating Sunscreen Moisturizer Broad Spectrum Spf50 50ml

Naked Sundays Cabana Creme Hydrating Sunscreen Moisturizer Broad Spectrum Spf50 50ml
SPL v6
SPL
SPL Set ID 04293280-e74a-f293-e063-6394a90a06f6
Route
TOPICAL
Published
Effective Date 2023-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g)
Inactive Ingredients
Citric Acid Monohydrate Sodium Hydroxide Hyaluronate Sodium Edetate Disodium Anhydrous Alpha-tocopherol Acetate Dimethicone Potassium Cetyl Phosphate Glyceryl Monostearate Sodium Polyacrylate (2500000 Mw) Niacinamide Water Hydroxyacetophenone Sodium Benzoate Glyceryl Caprylate Phenoxyethanol Ethylhexyl Methoxycrylene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-30
Description

Avobenzone 3% Homosalate 10% Octilsalate 5%

Purpose

Sunscreen

Medication Information

Indications and Usage

Directions:

Apply generously 15 minutes before sun

exposure.

Reapply after 80 minutes of swimming or

sweating.

Reapply immediately after towel drying.

Reapply at least every 2 hours.

Children under 6 months of age:

Ask a doctor.

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

10AM - 2PM

Wear long-sleeved shirts, pants, hats, and

sunglasses

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octilsalate 5%

Uses

Use:

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.

Label

Section 50565-1

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

Section 54433-8

Directions: Apply generously 15 minutes before

sun exposure. Use a water-resistant sunscreen if

swimming or sweating. Reapply immediately after

towel drying. Reapply 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 10AM - 2PM

Wear long-sleeved shirts, pants, hats, and

sunglasses Children under 6 months of age: Ask a

doctor.

Warnings

Warnings: For external use only.

Skin Cancer/Skin Aging Alert: Spending

time in the sun increases your risk of skin

cancer and early skin aging. This product

has been shown only to help prevent

sunburn, not skin cancer or early skin

aging. 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 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.

Use a water-resistant sunscreen if

swimming or sweating

Directions
  • SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
  • Reapply after 80 minutes of swimming or sweating.
  • Reapply immediately after towel drying.
  • Reapply at least every 2 hours.
  • Children under 3 years of age: Ask a doctor.

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 10.00AM - 2.00PM
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information

Other Information:

Protect the product in this container

from excessive heat and direct sun.

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octilsalate 5%

Inactive Ingredients

Inactive Ingredients:

Water, Butyloctyl Salicylate, Ethylhexyl

Methoxycrylene, Dimethicone, Potassium

Cetyl Phosphate, Glyceryl Stearate, Sodium

Polyacrylate, Niacinamide, Tocopheryl

Acetate, Hydroxyacetophenone, Sodium

Benzoate, Glyceryl Caprylate, Sodium

Hyaluronate, Disodium EDTA, Citric Acid,

Sodium Hydroxide

Structured Label Content

Uses (USES)

Use:

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.

Label

Indications and Usage (34067-9)

Directions:

Apply generously 15 minutes before sun

exposure.

Reapply after 80 minutes of swimming or

sweating.

Reapply immediately after towel drying.

Reapply at least every 2 hours.

Children under 6 months of age:

Ask a doctor.

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

10AM - 2PM

Wear long-sleeved shirts, pants, hats, and

sunglasses

Section 50565-1 (50565-1)

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

Section 54433-8 (54433-8)

Directions: Apply generously 15 minutes before

sun exposure. Use a water-resistant sunscreen if

swimming or sweating. Reapply immediately after

towel drying. Reapply 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 10AM - 2PM

Wear long-sleeved shirts, pants, hats, and

sunglasses Children under 6 months of age: Ask a

doctor.

Purpose

Sunscreen

Warnings (WARNINGS)

Warnings: For external use only.

Skin Cancer/Skin Aging Alert: Spending

time in the sun increases your risk of skin

cancer and early skin aging. This product

has been shown only to help prevent

sunburn, not skin cancer or early skin

aging. 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 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.

Use a water-resistant sunscreen if

swimming or sweating

Directions (DIRECTIONS)
  • SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
  • Reapply after 80 minutes of swimming or sweating.
  • Reapply immediately after towel drying.
  • Reapply at least every 2 hours.
  • Children under 3 years of age: Ask a doctor.

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 10.00AM - 2.00PM
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information (OTHER INFORMATION)

Other Information:

Protect the product in this container

from excessive heat and direct sun.

Active Ingredients (ACTIVE INGREDIENTS)

Avobenzone 3%

Homosalate 10%

Octilsalate 5%

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive Ingredients:

Water, Butyloctyl Salicylate, Ethylhexyl

Methoxycrylene, Dimethicone, Potassium

Cetyl Phosphate, Glyceryl Stearate, Sodium

Polyacrylate, Niacinamide, Tocopheryl

Acetate, Hydroxyacetophenone, Sodium

Benzoate, Glyceryl Caprylate, Sodium

Hyaluronate, Disodium EDTA, Citric Acid,

Sodium Hydroxide

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:50.413292 · Updated: 2026-03-14T23:08:10.789867