Safe Harbor Natural Suncare

Manufacturer
Emilia Personal Care Inc.
Effective date
2013-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:03

Label at a glance#

ProductSafe Harbor - Natural Anti-Aging Sunscreen Broad Spectrum SPF30 Sunscreen Sensitive Skin
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 sections

Indications and uses

helps prevent sunburn If used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweating Children under 6 months: ask a doctor Sun Protection Measures : Spending time in the sun increases your risk of sun 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 11.4%
Zinc Oxide 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • If used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

  • damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use water resistant sunscreen if swimming or sweating
  • Children under 6 months: ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of sun 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 10a.m. - 2p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cyclopentasiloxane, caprylic/capric triglyceride, C12-15 alkyl benzoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, cetyl dimethicone, phenyl trimethicone, phenoxyethanol, ethylhexylglycerin, trimethoxycaprylylsilane, sodium chloride, hydrogenated castor oil, microcrystaline wax, lavandula angustifolia (lavander) oil, tocopheryl acetate (vitamin E), aloe barbadensis leaf juice, allantoin, panthenol (pro-vitamin B5), lecithin, soy isoflavones, polysorbate 80, hippophae rhamnoides oil, bisabolol, camomilla recutita (matricaria) flower extract, tilia vulgaris (linden blossom) flower extract, melissa officinalis (lemon balm) leaf extract, aspalanthus linearis (rooibos) leaf extract, sodium lactate, porphyra umbilicalis extract

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safe Harbor™ Natural Suncare

Free from chemical UV filters

30 Mineral SPF Broad Spectrum Sunscreen

Sensitive Lotion
With Natural Anti-Aging Complex

Moisturizing sunscreen lotion

Anti-aging treatment
rich in age-defying antioxidants

4 Fl. Oz (118.3 mL)

Distributed by: Emilia Personal Care.
Manufactured in Israel.
For more information visit: www.safeharborsuncare.com

UVA, UVB
With Certified Organic Ingredients
Water Resistant
Allergy Tested

ZX226 2E T1

Label
Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42421-226-112020-01-31C16284748780-19d75b9d0-b5a5-f424-e053-dadaa90a57ceSafe Harbor Natural Suncare

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42421-226-11Safe Harbor - Natural Anti-Aging Sunscreen Broad Spectrum SPF30 Sunscreen Sensitive Skin118.3 mL in 1 TUBELOTION118.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42421-226SAFE HARBOR - NATURAL ANTI-AGING SUNSCREEN BROAD SPECTRUM SPF30 SUNSCREEN SENSITIVE SKIN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]1Legacy NDC, 1 package rows20140105_730659cc-f4b6-49a0-9459-42652723fd1f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ASPALATHUS LINEARIS LEAFINACTIVE INGREDIENTH7UGK1GJCU1
CETYL DIMETHICONE 150INACTIVE INGREDIENT5L694Y0T221
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0X1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIPPOPHAE RHAMNOIDES FRUIT OILINACTIVE INGREDIENTTA4JCF9S1J1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM621
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE92191
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PORPHYRA UMBILICALISINACTIVE INGREDIENT14AN0J70WO1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QT1
SOY ISOFLAVONESINACTIVE INGREDIENT71B37NR06D1
TILIA X EUROPAEA FLOWERINACTIVE INGREDIENTNHV2K1OUDH1
TRICAPRYLININACTIVE INGREDIENT6P928589881
TRIMETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTFZ07E4LW2M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42421-22642421-226-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

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 6 · 334 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / SUBCUTANEOUS0.7 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBMUCOSAL16 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / OPHTHALMIC13 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVESICAL351 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET / ORAL232 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, LIQUID FILLED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, FILM COATED / ORAL17 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / VAGINAL0.4 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / NASAL7.4 mg/1mlExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.68 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii candidate
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / EPIDURAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM LACTATESODIUM LACTATETU7HW0W0QTSUSPENSION / ORAL20 mg/1mlExact identifier — unii candidate
7 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / RECTAL315 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XELIXIR / ORAL1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1800 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR5 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPOWDER / ORAL66 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INFILTRATION648 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVITREAL10 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPOWDER, FOR SUSPENSION / ORAL396 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPASTE / ORAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYSTEM / IONTOPHORESIS3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii candidate
4 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE, DELAYED RELEASE / ORAL3.1 mgExact identifier — unii candidate
12 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
730659cc-f4b6-49a0-9459-42652723fd1f730659cc-f4b6-49a0-9459-42652723fd1f2013-11-19WarningsExact identifier
spl id: 730659cc-f4b6-49a0-9459-42652723fd1f
spl set id: 730659cc-f4b6-49a0-9459-42652723fd1f

Reported adverse events (FAERS/openFDA)#

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