Indications and 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.
H2O+ Hydration Sensitive Sunscreen Lotion SPF 30 Broad Spectrum SPF 30 Sunscreen
- Manufacturer
- Oxygen Development LLC
- Effective date
- 2022-01-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:46:25
Label at a glance#
ProductMoisturizer
Active ingredientZINC OXIDE
Label structure14 sections
Dosage and administration
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 prote...
Label contents#
Full prescribing information#
Active ingredient
Zinc Oxide 17%
Purpose
Sunscreen
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.
Warnings
For external use only.
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.
Stop use
Stop use and ask a dosctor if rash occurs.
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.
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
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)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-042-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7a72-d83d-e063-dadaa90ab31f | H2O+ Hydration Sensitive Sunscreen Lotion SPF 30 Broad Spectrum SPF 30 Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-042-01 | Moisturizer | 100 mg in 1 TUBE | LOTION | 100 | 1 | |
| 61354-042-02 | Moisturizer | 1 in 1 CARTON | LOTION | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Moisturizer
- Zinc Oxide
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61354-042 | 61354-042-01, 61354-042-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d4c8204e-596c-5978-e053-2995a90a3dfc | d4c8204e-596b-5978-e053-2995a90a3dfc | 2022-01-04 | Warnings | d4c8204e-596c-5978-e053-2995a90a3dfc d4c8204e-596b-5978-e053-2995a90a3dfc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.