H2o+ Hydration Sensitive Sunscreen Lotion Spf 30 Broad Spectrum Spf 30 Sunscreen

H2o+ Hydration Sensitive Sunscreen Lotion Spf 30 Broad Spectrum Spf 30 Sunscreen
SPL v1
SPL
SPL Set ID d4c8204e-596b-5978-e053-2995a90a3dfc
Route
TOPICAL
Published
Effective Date 2022-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (5 mg)
Inactive Ingredients
Coco-caprylate/caprate Sorbitan Olivate Polyglyceryl-3 Stearate Hydrogenated Soybean Lecithin Silicon Dioxide Dimethicone Isostearic Acid Propanediol Polyglyceryl-3 Pentaricinoleate Glycerin Water Medium-chain Triglycerides Stearyl/octyldodecyl Citrate Crosspolymer Polyhydroxystearic Acid (2300 Mw) Glyceryl Stearate Citrate Lecithin, Sunflower Cetearyl Olivate Glyceryl Caprylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-01-04

Description

Zinc Oxide 17%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 17%

Uses

helps prevent sunburn protection. Higher SPF gives more sunburn protection. 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 51945-4

Stop Use

Stop use and ask a dosctor if rash occurs.

Warnings

For external use only.

Directions

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: Ask a doctor.

Reapply at least every 2 hours.

use a water resistant sunscreen if swimming or sweating.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease thsi risk, regulary use a sunscreen with a Board 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

Do Not Use

Do not use on damage or broken skin.

When Using

When using this product keep out of eyes. Rinse with water to remove.

Active Ingredient

Zinc Oxide 17%

Other Information

Protect the protect in this container from excessive heat and direct sun

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Cetearyl Olivate, Glyceryl Stearate Citrate, Stearyl/Octyldodecyl Citrate Crosspolymer, Dimethicone, Camellia Japonica Seed Oil, Glycolipids, Trehalose, Pullulan, Agastache Mexicana Flower/Leaf/Stem Extract, Camellia Oleifera Leaf Extract, Glycine, Alanine, Serine, Threonine, Chamomilla Recutita (Matricaria) Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Polylysine, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Hydrogenated Lecithin, Silica, Xanthan Gum, Cetearyl Alcohol, Tocopheryl Acetate, Mica, Tocopheryl, Sclerotium Gum, Glycerin, Caprylhydroxamic Acid, Titanium Dioxide (CI 77891) (090-50132-000)

Keep Out the Reach of Children

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


Structured Label Content

Uses

helps prevent sunburn protection. Higher SPF gives more sunburn protection. 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 51945-4 (51945-4)

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a dosctor if rash occurs.

Warnings

For external use only.

Directions

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: Ask a doctor.

Reapply at least every 2 hours.

use a water resistant sunscreen if swimming or sweating.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease thsi risk, regulary use a sunscreen with a Board 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

Do Not Use (Do not use)

Do not use on damage or broken skin.

When Using (When using)

When using this product keep out of eyes. Rinse with water to remove.

Active Ingredient (Active ingredient)

Zinc Oxide 17%

Other Information (Other information)

Protect the protect in this container from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Cetearyl Olivate, Glyceryl Stearate Citrate, Stearyl/Octyldodecyl Citrate Crosspolymer, Dimethicone, Camellia Japonica Seed Oil, Glycolipids, Trehalose, Pullulan, Agastache Mexicana Flower/Leaf/Stem Extract, Camellia Oleifera Leaf Extract, Glycine, Alanine, Serine, Threonine, Chamomilla Recutita (Matricaria) Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Polylysine, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Hydrogenated Lecithin, Silica, Xanthan Gum, Cetearyl Alcohol, Tocopheryl Acetate, Mica, Tocopheryl, Sclerotium Gum, Glycerin, Caprylhydroxamic Acid, Titanium Dioxide (CI 77891) (090-50132-000)

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

​Keep out the 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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