FDA.reportPublic FDA data

Natures Gate

Manufacturer
Levlad, LLC
Effective date
2017-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:09:05

Label at a glance#

ProductNatures Gate Kids SPF 20 Mineral
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 sections

Indications and uses

helps prevent sunburn 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

Dosage and administration

apply liberally and evenly 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 ot...

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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 8.3%
Zinc oxide 2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • 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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

allantoin, aloe barbadensis leaf juice, althaea officinalis (marshmallow) root extract, bisabolol, butyrospermum parkii (shea) butter, calendula officinalis flower extract, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetearyl alcohol, cetearyl wheat straw glycosides, chamomilla recutita (matricaria) flower extract, dehydroxanthan gum, diisopropyl adipate, dimethicone, ethylhexylglycerin, euterpe oleracea (açai) fruit extract, glycerin, glyceryl stearate, glyceryl undecylenate, hydrastis canadensis (golden seal) extract, phenoxyethanol, polysorbate 80, propylheptyl caprylate, prunus armeniaca (apricot) kernel oil, stearic acid, stearyl alcohol, triethoxycaprylylsilane, viola tricolor (wild pansy) extract, water.

Questions or comments?

OTC - QUESTIONS SECTION

1 (800) 327-2012

Monday – Friday 8 a.m. – 5 p.m. PST

SPL UNCLASSIFIED SECTION

Distributed by Nature's Gate
Chatsworth, CA 91311

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATURE'S
GATE®

Mineral
Sunscreen

KIDS

Vegan Sunscreen

Broad Spectrum
SPF 20

Water Resistant
(40 minutes)

4 FL OZ / 118 mL

Principal Display Panel - 118 mL Tube Label
Principal Display Panel - 118 mL Tube Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
.ALPHA.-BISABOLOL, (+/-)-INACTIVE INGREDIENT36HQN158VC1
ACAIINACTIVE INGREDIENT46AM2VJ0AW1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ALTHAEA OFFICINALIS ROOTINACTIVE INGREDIENTTRW2FUF47H1
APRICOT KERNEL OILINACTIVE INGREDIENT54JB35T06A1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CETYL GLUCOSIDEINACTIVE INGREDIENT0O529Z601A1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72X1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL 1-STEARATEINACTIVE INGREDIENT258491E1RZ1
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JV1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PROPYLHEPTYL CAPRYLATEINACTIVE INGREDIENT991Z19V2OD1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
STEARYL GLUCOSIDEINACTIVE INGREDIENT880752Z9EG1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
VIOLA TRICOLORINACTIVE INGREDIENT9Q24RAI43V1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

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
61380-31061380-310-27

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER OIL65UEH262ISIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL GLUCOSIDE0O529Z601AIACT
STEARYL GLUCOSIDE880752Z9EGIACT
CHAMOMILEFGL3685T2XIACT
XANTHAN GUMTTV12P4NEEIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ACAI46AM2VJ0AWIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL 1-STEARATE258491E1RZIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
GOLDENSEALZW3Z11D0JVIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLHEPTYL CAPRYLATE991Z19V2ODIACT
APRICOT KERNEL OIL54JB35T06AIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
VIOLA TRICOLOR9Q24RAI43VIACT
WATER059QF0KO0RIACT

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 5 · 266 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRASYNOVIAL0.2 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
DIISOPROPYL ADIPATEDIISOPROPYL ADIPATEP7E6YFV72XGEL / TOPICAL150 mgExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL 1-STEARATEGLYCERYL 1-STEARATE258491E1RZCAPSULE / ORAL1 mgExact identifier — unii candidate
3 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YTABLET, EXTENDED RELEASE / ORAL244 mgExact identifier — unii candidate
12 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / TOPICAL0.98 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii candidate
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii candidate
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YLOTION / TOPICAL1140 mgExact identifier — unii candidate
12 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / ORAL206 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 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
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 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
1516b27f-1252-48bf-ac45-facbff0678a8ae8ef7f0-1dae-4ec8-967c-d7ba8adfb1532020-06-08WarningsExact identifier
spl set id: ae8ef7f0-1dae-4ec8-967c-d7ba8adfb153

Reported adverse events (FAERS/openFDA)#

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