FDA.reportPublic FDA data

PEAK Sunscreen 100 Natural SPF 30

Manufacturer
Peak Inc
Effective date
2017-02-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:19:29

Label at a glance#

ProductPEAK Sunscreen 100 Natural SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps Prevent Sunburn. If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

App l y 15 minutes before sun exposure. Reapply: At l east every two-hours. Immediately after swimming, sweating or towel drying. SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad-spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Limit time in t...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6.00%

Zinc Oxide 6.00%

Purpose

OTC - PURPOSE SECTION

   Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps Prevent Sunburn.
  • If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

WARNINGS SECTION

  • For externa l use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and consu lt physician

OTC - STOP USE SECTION

if irritation or rash develops .

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swal lowed, get medica l attention or contact Poison Contro l center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • App ly 15 minutes before sun exposure.
  • Reapply:
  • At least every two-hours.
  • Immediately after swimming, sweating or towel drying.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad-spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

  • Limit time in the sun, especial ly between 10am and 2pm.
  • Wear long s leeve shirts, pants, hats and sunglasses.
  • For children under 6 months, consult a physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

A loe barbadensis(aloe vera) extract, beeswax, camelia sinensis (green tea) leaf extract, cocos nucifera (coconut) oil, cucumis sativus (cucumber) fruit extract, daucus carota sativa (carrot) extract, helianthus annuus (sunflower) seed oil, punica granatum (pomegranate)extract, tocopheryl acetate (vitamin E).

Other information

SPL UNCLASSIFIED SECTION

  • Do not store in excessive heat or direct sunlight.

Distributed by:

SPL UNCLASSIFIED SECTION

Peak Inc.2416 W. Victory B lvd #192, Burbank, CA. 91506

Questions or comments?

OTC - QUESTIONS SECTION

Contact us via our websit at www.peak-prod.com

Package Lebeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
ZINC CATIONACTIVE MOIETY13S1S8SF372
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ12
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
CARROTINACTIVE INGREDIENTL56Z1JK48B2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L2
CUCUMBERINACTIVE INGREDIENTYY7C30VXJT2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
PUNICA GRANATUM ROOT BARKINACTIVE INGREDIENTCLV24I3T1D2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70238-70270238-702-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
YELLOW WAX2ZA36H0S2VIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
COCONUT OILQ9L0O73W7LIACT
CUCUMBERYY7C30VXJTIACT
CARROTL56Z1JK48BIACT
SUNFLOWER OIL3W1JG795YIIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 25 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates

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
0749c3b9-66dd-2fe4-e063-6394a90aae11bc0797ae-c3a0-4983-bd4e-19c3fc5551052023-10-09WarningsExact identifier
spl set id: bc0797ae-c3a0-4983-bd4e-19c3fc555105

Reported adverse events (FAERS/openFDA)#

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