Natures Gate kids block SPF 50

Dosage form: lotion
Ingredients: OCTINOXATE 75mg in 1mL, OCTISALATE 50mg in 1mL, OCTOCRYLENE 70mg in 1mL, ZINC OXIDE 69mg in 1mL
Labeler: Levlad, LLC
NDC Code: 61380-279

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.

Nature's Gate ®
kid's
block SPF 50

DIRECTIONS

Apply liberally and evenly 30 minutes before sun exposure. Reapply as needed 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 or irritation develops and lasts.

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

ACTIVE INGREDIENTS:

Octinoxate 7.5%, Octisalate 5%, Octocrylene 7%, Zinc Oxide 6.9%

INACTIVE INGREDIENTS

Water, Polyglyceryl-2 Dipolyhydroxystearate, Neopentyl Glycol Diethylhexanoate, Polyglyceryl-4 Isostearate, Isopropyl Palmitate, Cetyl Dimethicone, Glycerin, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Calendula Officinalis Flower Extract, Tocopheryl Acetate, Magnesium Sulfate, Neopentyl Glycol Diisostearate, Sodium Chloride, Triethoxycaprylylsilane, Caprylyl Glycol, Caprylhydroxamic Acid.

Distributed by Nature's Gate • Chatsworth, CA 91311

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

Nature's Gate ®

kid's
block SPF 50

pediatrician tested
sunscreen | lotion

with aloe vera
UVA/UVB protection
fragrance-free
paraben-free

4 FL OZ / 118 mL

NATURES GATE   KIDS BLOCK SPF 50
octinoxate, octisalate, octocrylene, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61380-279
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE70 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE69 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
NEOPENTYL GLYCOL DIETHYLHEXANOATE 
POLYGLYCERYL-4 ISOSTEARATE 
ISOPROPYL PALMITATE 
GLYCERIN 
MEDIUM-CHAIN TRIGLYCERIDES 
ALOE VERA LEAF 
CHAMOMILE 
ROSEMARY 
CALENDULA OFFICINALIS FLOWER 
ALPHA-TOCOPHEROL ACETATE 
MAGNESIUM SULFATE, UNSPECIFIED 
NEOPENTYL GLYCOL DIISOSTEARATE 
SODIUM CHLORIDE 
TRIETHOXYCAPRYLYLSILANE 
CAPRYLYL GLYCOL 
CAPRYLHYDROXAMIC ACID 
Packaging
#Item CodePackage Description
1NDC:61380-279-27118 mL in 1 TUBE
2NDC:61380-279-247 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/24/2011
Labeler - Levlad, LLC (076245109)
Establishment
NameAddressID/FEIOperations
Levlad LLC076245109MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 09/2011
 
Levlad, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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