Naked Sundays Cabana Clear Water Gel Serum 30ml

Naked Sundays Cabana Clear Water Gel Serum 30ml
SPL v7
SPL
SPL Set ID 0426b1e9-063b-c1e6-e063-6294a90a2554
Route
TOPICAL
Published
Effective Date 2021-09-01
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 Hyaluronate Sodium Edetate Disodium Anhydrous Alpha-tocopherol Acetate Polyacrylate-1 Crosspolymer Glycerin Ethylhexylglycerin Sodium Hydroxide Kakadu Plum Water Butyloctyl Salicylate Propylene Glycol Acrylates Crosspolymer-4 Phenoxyethanol Hydroxyacetophenone

Identifiers & Packaging

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

Description

Avobenzone 3% Homosalate 10% Octilsalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octilsalate 5%

Uses

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 43685-7

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

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,

Propylene Glycol, Acrylates

Copolymer, Euphorbia Cerifera

(Candelilla) Wax, Phenoxyethanol,

Hydroxyacetophenone,

Acrylates/C10-30 Alkyl Acrylate

Crosspolymer, Glycerin, Tocopheryl

Acetate, Polyacrylate

Crosspolymer-6, Ethylhexylglycerin,

Sodium Hyaluronate, Sodium

Hydroxide, Terminalia Ferdinandiana

(Kakadu Plum) Fruit Extract,

Disodium EDTA, Citric Acid


Structured Label Content

Uses (USES)

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 43685-7 (43685-7)

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,

Propylene Glycol, Acrylates

Copolymer, Euphorbia Cerifera

(Candelilla) Wax, Phenoxyethanol,

Hydroxyacetophenone,

Acrylates/C10-30 Alkyl Acrylate

Crosspolymer, Glycerin, Tocopheryl

Acetate, Polyacrylate

Crosspolymer-6, Ethylhexylglycerin,

Sodium Hyaluronate, Sodium

Hydroxide, Terminalia Ferdinandiana

(Kakadu Plum) Fruit Extract,

Disodium EDTA, Citric Acid


Advanced Ingredient Data


Raw Label Data

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