H Skin Repair - Hydrate plus Restore Sunscreen SPF 30

Manufacturer
Cosmetic Solutions LLC
Effective date
2019-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:35

Label at a glance#

ProductH Skin Repair - Hydrate plus Restore Sunscreen SPF 30
Active ingredientOctinoxate, Zinc Oxide
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: Ask a doctor. 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 Spectru...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octyl Methoxycinnamate 7.5%

Zinc Oxide 7.0%.

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: Ask a doctor.

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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Stearyl Alcohol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate, Cetearyl Alcohol, Beeswax, Dimethicone, Cyclomethicone , Diisopropyl Adipate, Hexylene Glycol, PEG-40 Stearate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, PEG-20, Carnauba Wax, Dimethicone Copolyol, VP/Eicosene Copolymer, Sorbitan Tristearate, Stearoxytrimethylsilane, Steareth-100, Laureth-7, C13-14 Isoparaffin, Phenoxyethanol, Ethyhexylglycerin, Polyacrylamide.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H
skin repair

HYDRATE + RESTORE

sunscreen spf 30+blemish fix
mineral moisture cream

with broad spectrum UVA/UVB
7% zinc oxide, natural beeswax & carnauba

helps reduce the appearance of
redness + repair damaged + dry skin

1 FLUID OUNCE (30mL)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-6404-12021-01-29C16284748780-1ba0f9c33-3312-a910-e053-dadaa90a0b85H Skin Repair - Hydrate + Restore Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-6404-1H Skin Repair - Hydrate plus Restore Sunscreen SPF 3030 g in 1 BOTTLE, PLASTICCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-6404H SKIN REPAIR - HYDRATE PLUS RESTORE SUNSCREEN SPF 30 (OCTINOXATE AND ZINC OXIDE) CREAM [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20190927_16212981-e808-4f74-a764-4f81aa6d0e45.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-640466163-6404-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c41b2edd-2ec7-4fa9-990b-4a65c58e7ae616212981-e808-4f74-a764-4f81aa6d0e452019-09-26WarningsExact identifier
spl id: c41b2edd-2ec7-4fa9-990b-4a65c58e7ae6
spl set id: 16212981-e808-4f74-a764-4f81aa6d0e45

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.