Hydro Essence

Hydro Essence
SPL v1
SPL
SPL Set ID f176c1b1-f539-417f-98b5-69d99365f2f2
Route
TOPICAL
Published
Effective Date 2025-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (10 g) Octinoxate (7.5 g)
Inactive Ingredients
Water Oleth-3 Phosphate Cyclomethicone 5 Isopropyl Palmitate Hydrogenated Soybean Oil Medium-chain Triglycerides Glycerin Dimethicone, Unspecified Apple Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Oleth-10 Polygonum Aviculare Top Hyaluronate Sodium .alpha.-tocopherol Acetate Ethylhexylglycerin Soybean Lecithin Xanthan Gum Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Caprylyl Glycol Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Peg-7 Trimethylolpropane Coconut Ether Edetate Disodium Polyisobutylene (1000 Mw) Triethoxycaprylylsilane 1,2-hexanediol C15-23 Alkane Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Zinc Oxide 10% Octinoxate 7.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 10% 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

Zinc Oxide 10%

Octinoxate 7.5%

Knotweed

MEDICAL GRADE

SHIELD

RECOMMENDED FOR

• COMBO  • NORMAL

• DRY        • SENSITIVE

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 dryings • 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 10%

Octinoxate 7.5%

Other Information

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

Inactive Ingredients

Water/Aqua/Eau, Oleth-3 Phosphate, Cyclopentasiloxane, Isopropyl Palmitate, Hydrogenated Soybean Oil, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Plankton Extract, Apple (Pyrus Malus) Fruit Extract, Hydroxyethyl, Oleth-10, Knot Grass (Polygonum Aviculare) Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Lecithin, Hydrogenated Soy Polyglycerides, Xanthan Gum, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-450/50 Trimethylolpropane Lauryl Ether, PEG-7 Trimethylolpropane Coconut Ether, Disodium EDTA, Polyisobutene, Triethoxycaprylylsilane, 1,2 Hexanediol, C15-23 Alkane, Phenoxyethanol


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

Zinc Oxide 10%

Octinoxate 7.5%

Knotweed

MEDICAL GRADE

SHIELD

RECOMMENDED FOR

• COMBO  • NORMAL

• DRY        • SENSITIVE

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 dryings • 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 10%

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, Oleth-3 Phosphate, Cyclopentasiloxane, Isopropyl Palmitate, Hydrogenated Soybean Oil, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Plankton Extract, Apple (Pyrus Malus) Fruit Extract, Hydroxyethyl, Oleth-10, Knot Grass (Polygonum Aviculare) Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Lecithin, Hydrogenated Soy Polyglycerides, Xanthan Gum, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-450/50 Trimethylolpropane Lauryl Ether, PEG-7 Trimethylolpropane Coconut Ether, Disodium EDTA, Polyisobutene, Triethoxycaprylylsilane, 1,2 Hexanediol, C15-23 Alkane, Phenoxyethanol


Advanced Ingredient Data


Raw Label Data

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