NATURES GATE KIDS BLOCK SPF 30 SUNSCREEN- octinoxate, octocrylene, oxybenzone and titanium dioxide lotion 
Levlad, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Natures Gate® Kids Block SPF 30 Sunscreen

This fragrance-free sunscreen is specially formulated for children's skin. Our formula contains Aloe Extract for its skin calming properties and Bisabolol, the key ingredient in Chamomile, for its soothing benefits.

DIRECTIONS

Apply liberally and evenly 30 minutes before sun exposure. Reapply every 2 hours or after towel drying, swimming or perspiring. Children under 6 months of age: ask a doctor.

WARNINGS

For external use only. 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.

ACTIVE INGREDIENTS

Octinoxate 7.5%, Octocrylene 7%, Oxybenzone 4%, Titanium Dioxide 5%

INACTIVE INGREDIENTS

Water, Lavandula Intermedia (Lavender) Flower/Leaf/Stem Extract, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Sorbitol, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, Coffea Arabica (Coffee) Seed Extract, Viola Tricolor (Pansy) Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Frangula Alnus (Buckthorn) Bark Extract, Cola Acuminata (Kola) Seed Extract, Pfaffia Paniculata (Suma) Root Extract, Echinacea Purpurea (Coneflower) Root Extract, Equisetum Hiemale (Horsetail) Extract, Rosa Canina (Rosehips) Fruit Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Cucumis Sativus (Cucumber) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Glycerin, Sorbitan Stearate, Bisabolol, Cetearyl Alcohol, Ceteareth-20, Dimethicone, Tromethamine, Carbomer, Glyceryl Undecylenate, Ethylhexylglycerin, Sodium Metaphosphate, Phenoxyethanol.

Distributed by Nature's Gate
Chatsworth, CA 91311

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Nature's Gate®

kid's
block SPF 30

fragrance-free

sunscreen | lotion

with Aloe Vera

paraben-free
pediatrician tested

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
NATURES GATE KIDS BLOCK SPF 30 SUNSCREEN 
octinoxate, octocrylene, oxybenzone, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61380-125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAVANDULA X INTERMEDIA FLOWERING TOP (UNII: 7162192091)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
SORBITOL (UNII: 506T60A25R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
VIOLA TRICOLOR (UNII: 9Q24RAI43V)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FRANGULA ALNUS BARK (UNII: S2D77IH61R)  
COLA ACUMINATA SEED (UNII: 1F8VIW1479)  
PFAFFIA PANICULATA ROOT (UNII: KYV09BQ2YN)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
EQUISETUM HYEMALE (UNII: 59677RXH25)  
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
ORANGE PEEL (UNII: TI9T76XD44)  
CUCUMBER (UNII: YY7C30VXJT)  
ROSEMARY (UNII: IJ67X351P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61380-125-11118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/200804/06/2012
Labeler - Levlad, LLC (076245109)
Establishment
NameAddressID/FEIBusiness Operations
Levlad, LLC076245109MANUFACTURE(61380-125) , ANALYSIS(61380-125) , LABEL(61380-125) , PACK(61380-125)

Revised: 7/2015
 
Levlad, LLC