NATURES GATE KIDS SPF 20 MINERAL- titanium dioxide and zinc oxide lotion

Natures Gate by

Drug Labeling and Warnings

Natures Gate by is a Otc medication manufactured, distributed, or labeled by Levlad, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Titanium dioxide 8.3%
Zinc oxide 2%

Purpose

Sunscreen

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

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

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

Directions

• 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

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

Inactive ingredients

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?

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

NATURE'S
GATE®

Mineral
Sunscreen

KIDS

Vegan Sunscreen

Broad Spectrum
SPF 20

Water Resistant
(40 minutes)

4 FL OZ / 118 mL

INGREDIENTS AND APPEARANCE

NATURES GATE   KIDS SPF 20 MINERAL
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61380-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	83 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL GLUCOSIDE (UNII: 0O529Z601A)
STEARYL GLUCOSIDE (UNII: 880752Z9EG)
CHAMOMILE (UNII: FGL3685T2X)
XANTHAN GUM (UNII: TTV12P4NEE)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACAI (UNII: 46AM2VJ0AW)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
GOLDENSEAL (UNII: ZW3Z11D0JV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
VIOLA TRICOLOR (UNII: 9Q24RAI43V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61380-310-27	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/12/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/12/2012

Labeler - Levlad, LLC (076245109)

Establishment
Name	Address	ID/FEI	Business Operations
Levlad, LLC		076245109	MANUFACTURE(61380-310) , ANALYSIS(61380-310) , LABEL(61380-310) , PACK(61380-310)