Sheer Defense Tinted Spf 46

Sheer Defense Tinted Spf 46
SPL v5
SPL
SPL Set ID 017265e9-31e6-43ce-9432-cb88f471c496
Route
TOPICAL
Published
Effective Date 2025-02-20
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 Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Polyisobutylene (1000 Mw) Peg-7 Trimethylolpropane Coconut Ether Ethylhexylglycerin .alpha.-tocopherol Acetate, Dl- Triethoxycaprylylsilane Edetate Disodium Anhydrous Hyaluronate Sodium Phenoxyethanol Ferric Oxide Yellow Ferric Oxide Red Ferrosoferric Oxide

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, Glycerin, Knot Grass (Polygonum Aviculare) Extract, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Ethylhexylglycerin, Tocopheryl Acetate, Triethoxycaprylylsilane, Disodium EDTA, Sodium Hyaluronate, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)


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, Glycerin, Knot Grass (Polygonum Aviculare) Extract, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Ethylhexylglycerin, Tocopheryl Acetate, Triethoxycaprylylsilane, Disodium EDTA, Sodium Hyaluronate, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)