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

Purpose

Sunscreen

Description

Zinc Oxide 12% Octinoxate 7.5%


Medication Information

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

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.

Purpose

Sunscreen

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

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)

Description

Zinc Oxide 12% Octinoxate 7.5%

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.

Packaging

Drug Facts

Active Ingredient

Zinc Oxide 12%

Octinoxate 7.5%


Structured Label Content

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

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.

Purpose

Sunscreen

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

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)

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.

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Zinc Oxide 12%

Octinoxate 7.5%


Advanced Ingredient Data


Raw Label Data

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