Clear Defense Spf 45

Clear Defense Spf 45
SPL v5
SPL
SPL Set ID d681d92f-3501-4fca-b629-096341f20ab1
Route
TOPICAL
Published
Effective Date 2025-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (12 g) Octinoxate (7.5 g)
Inactive Ingredients
Water Cyclomethicone 5 Niacinamide Oleth-3 Phosphate Octyldodecyl Neopentanoate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Glycerin Polygonum Aviculare Top Polyisobutylene (1000 Mw) Peg-7 Trimethylolpropane Coconut Ether Ethylhexylglycerin .alpha.-tocopherol Acetate, Dl- Edetate Disodium Anhydrous Triethoxycaprylylsilane Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Phenoxyethanol Citric Acid Monohydrate Sodium Hydroxide Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-27

Description

Zinc Oxide 12% Octinoxate 7.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 12% Octinoxate 7.5%

Uses

• Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 42229-5

brand MD

Broad Spectrum Sunscreen

Zinc Oxide 12%

Octinoxate 7.5%

Niacinamide

MEDICAL GRADE

SHIELD

RECOMMENDED FOR

• ALL SKIN TYPES

GREEN LEAF PROGRAM

NOT TESTED ON ANIMALS

Distributed by:

brandMD®

Canoga Park, CA 91304

(818) 534-3180

www.brandMD.com

Section 50565-1

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

Warnings

For external use only

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

Packaging

Directions

• Apply liberally on a clean dry face, avoiding delicate eye area 15 minutes before sun exposure • 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 of age: Ask a doctor​

Drug Facts

Active Ingredient

Zinc Oxide 12%

Octinoxate 7.5%

Other Information

• protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water/Aqua/Eau, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (and), Glycerin, Knot Grass (Polygonum Aviculare) Extract, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Ethylhexylglycerin, Tocopheryl Acetate, Disodium EDTA, Triethoxycaprylylsilane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Phenoxyethanol, Citric Acid, Sodium Hydroxide, Sodium Hyaluronate


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.

Section 42229-5 (42229-5)

brand MD

Broad Spectrum Sunscreen

Zinc Oxide 12%

Octinoxate 7.5%

Niacinamide

MEDICAL GRADE

SHIELD

RECOMMENDED FOR

• ALL SKIN TYPES

GREEN LEAF PROGRAM

NOT TESTED ON ANIMALS

Distributed by:

brandMD®

Canoga Park, CA 91304

(818) 534-3180

www.brandMD.com

Section 50565-1 (50565-1)

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

Purpose

Sunscreen

Warnings

For external use only

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

Packaging

Directions

• Apply liberally on a clean dry face, avoiding delicate eye area 15 minutes before sun exposure • 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 of age: Ask a doctor​

Drug Facts

Active Ingredient (Active ingredient)

Zinc Oxide 12%

Octinoxate 7.5%

Other Information (Other information)

• protect the product in this container from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (and), Glycerin, Knot Grass (Polygonum Aviculare) Extract, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Ethylhexylglycerin, Tocopheryl Acetate, Disodium EDTA, Triethoxycaprylylsilane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Phenoxyethanol, Citric Acid, Sodium Hydroxide, Sodium Hyaluronate


Advanced Ingredient Data


Raw Label Data

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