Sheer Broad Spectrum Spf45

Sheer Broad Spectrum Spf45
SPL v11
SPL
SPL Set ID c7f05046-3641-4d7b-8399-f5c7c3e9ed33
Route
TOPICAL
Published
Effective Date 2020-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (99 mg) Octocrylene (80 mg) Octinoxate (75 mg) Octisalate (50 mg)
Inactive Ingredients
Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Cyclomethicone 5 Cyclomethicone 4 Ethylparaben Methylparaben Phenoxyethanol Phenyl Trimethicone Docosanol Butylparaben Alkyl (c12-15) Benzoate Propylparaben Silicon Dioxide Edetate Sodium .alpha.-tocopherol Acetate Triethoxycaprylylsilane Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-05-14 Until 2026-09-30

Description

9.9% Zinc Oxide 8.0% Octocrylene 7.5% Ethylhexyl Methoxycinnamate 5.0% Ethylhexyl Salicylate

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

9.9% Zinc Oxide 8.0% Octocrylene 7.5% Ethylhexyl Methoxycinnamate 5.0% Ethylhexyl Salicylate

Uses

• Helps prevent sunburn and provides a sun protection factor of 45.

• Ideal for daily use; can be applied under makeup.

Section 44425-7

Store at room temperature (15-30°C / 59-86°F).

Directions

• Apply daily to face, neck and chest.

• Apply liberally and evenly 15 minutes before sun exposure.

• Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing.

• For use on children less than 6 months of age, consult a healthcare practitioner.

• Use a water resistant sunscreen if swimming or sweating.

Drug Facts

Questions?

450 455 9779                           1 877 484 8437

Product Labels

250ml Packaging

Active Ingredients

9.9% Zinc Oxide

8.0% Octocrylene

7.5% Ethylhexyl Methoxycinnamate

5.0% Ethylhexyl Salicylate

Inactive Ingredients

BEHENYL ALCOHOL, BUTYLPARABEN, BUTYROSPERMUM PARKII, C12-15 ALKYL BENZOATE, CETEARETH-20, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, CYCLOTETRASILOXANE, ETHYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, PHENYL TRIMETHICONE, PROPYLPARABEN, SILICA, TETRASODIUM EDTA, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/EAU.

For External Use Only

• The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

When Using This Product

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

• Do not use on damaged or broken skin.

Stop Use and Ask A Doctor If

• Rash or irritation develops and lasts.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses (USES)

• Helps prevent sunburn and provides a sun protection factor of 45.

• Ideal for daily use; can be applied under makeup.

Section 44425-7 (44425-7)

Store at room temperature (15-30°C / 59-86°F).

Purpose (PURPOSE)

Sunscreen

Directions (DIRECTIONS)

• Apply daily to face, neck and chest.

• Apply liberally and evenly 15 minutes before sun exposure.

• Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing.

• For use on children less than 6 months of age, consult a healthcare practitioner.

• Use a water resistant sunscreen if swimming or sweating.

Drug Facts (DRUG FACTS)

Questions?

450 455 9779                           1 877 484 8437

Product Labels

250ml Packaging (250mL Packaging)

Active Ingredients (ACTIVE INGREDIENTS)

9.9% Zinc Oxide

8.0% Octocrylene

7.5% Ethylhexyl Methoxycinnamate

5.0% Ethylhexyl Salicylate

Inactive Ingredients (INACTIVE INGREDIENTS)

BEHENYL ALCOHOL, BUTYLPARABEN, BUTYROSPERMUM PARKII, C12-15 ALKYL BENZOATE, CETEARETH-20, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, CYCLOTETRASILOXANE, ETHYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, PHENYL TRIMETHICONE, PROPYLPARABEN, SILICA, TETRASODIUM EDTA, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/EAU.

For External Use Only (For external use only)

• The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

When Using This Product (When using this product)

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

• Do not use on damaged or broken skin.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• Rash or irritation develops and lasts.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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