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SPL v8
SPL
SPL Set ID 0ce809a1-45fb-9d4d-e063-6294a90a26a2
Route
topical
Published
Effective Date 2023-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (3.3 g) zinc oxide (14.9 g)
Inactive Ingredients
stannic oxide dimethicone ethylhexylglycerin aluminum hydroxide ethylhexyl methoxycrylene alkyl (c12-15) benzoate ferric oxide red isostearic acid water propanediol hydroxyacetophenone phenoxyethanol hibiscus sabdariffa flower hyaluronate sodium lauryl peg-8 dimethicone (300 cps) mica magnesium sulfate anhydrous polyglyceryl-3 pentaricinoleate stearic acid coco-caprylate/caprate isododecane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-06-30

Purpose

Sunscreen

Description

Active Ingredients: Titanium Dioxide 3.3% Zinc Oxide 14.9%


Medication Information

Warnings

Warnings: For external use only. Do not use

on damaged or broken skin Avoid prolonged

sun exposure. If it gets in your eyes, wash well

with water. Keep out of reach of children.

Stop use and ask a doctor if rashes occur.

If product is swallowed, get medical help or

contact a Poison Control Center right away.

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.

Purpose

Sunscreen

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 this product

from excess heat and direct sun. Store below

30°C / 86°F.

Inactive Ingredients

Inactive Ingredients: Aluminium Hydroxide,

Butyloctyl Salicylate, C12-15 Alkyl Benzoate,

Coco-Caprylate/Caprate, Dimethicone, Ethylhexyl

Methoxycrylene, Ethylhexylglycerin, Hibiscus

sabdariffa Flower Extract, Hydroxyacetophenone,

Iron Oxides/(CI 77499, CI 77491, CI 77492),

Isododecane, Isostearic Acid, Lauryl PEG-8

Dimethicone, Magnesium Sulfate, Mica/CI 77019,

Phenoxyethanol, Polyglyceryl-3 Polyricinoleate,

Propanediol, Purified Water, Silica, Sodium

Hyaluronate, Stearic Acid, Tin Oxide, Titanium

dioxide/CI 77891

Description

Active Ingredients: Titanium Dioxide 3.3% Zinc Oxide 14.9%

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: Shake well before use.

Apply liberally and reapply every 80 minutes,

especially after swimming or 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 lime in the sun,

especially from 10 am-2 pm Wear longsleeved

shirts, pants, hats, and sunglasses For

Children under 6 months of age ask a doctor

Section 55105-1

Sunscreen

Active Ingredients

Active Ingredients:

Titanium Dioxide 3.3%

Zinc Oxide 14.9%


Structured Label Content

Warnings (WARNINGS)

Warnings: For external use only. Do not use

on damaged or broken skin Avoid prolonged

sun exposure. If it gets in your eyes, wash well

with water. Keep out of reach of children.

Stop use and ask a doctor if rashes occur.

If product is swallowed, get medical help or

contact a Poison Control Center right away.

Uses (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.

Purpose

Sunscreen

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 this product

from excess heat and direct sun. Store below

30°C / 86°F.

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive Ingredients: Aluminium Hydroxide,

Butyloctyl Salicylate, C12-15 Alkyl Benzoate,

Coco-Caprylate/Caprate, Dimethicone, Ethylhexyl

Methoxycrylene, Ethylhexylglycerin, Hibiscus

sabdariffa Flower Extract, Hydroxyacetophenone,

Iron Oxides/(CI 77499, CI 77491, CI 77492),

Isododecane, Isostearic Acid, Lauryl PEG-8

Dimethicone, Magnesium Sulfate, Mica/CI 77019,

Phenoxyethanol, Polyglyceryl-3 Polyricinoleate,

Propanediol, Purified Water, Silica, Sodium

Hyaluronate, Stearic Acid, Tin Oxide, Titanium

dioxide/CI 77891

Label

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: Shake well before use.

Apply liberally and reapply every 80 minutes,

especially after swimming or 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 lime in the sun,

especially from 10 am-2 pm Wear longsleeved

shirts, pants, hats, and sunglasses For

Children under 6 months of age ask a doctor

Section 55105-1 (55105-1)

Sunscreen

Active Ingredients (ACTIVE INGREDIENTS)

Active Ingredients:

Titanium Dioxide 3.3%

Zinc Oxide 14.9%


Advanced Ingredient Data


Raw Label Data

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