KIDS BROAD SPECTRUM SPF 35- zinc oxide cream

Kids Broad Spectrum SPF 35 by

Drug Labeling and Warnings

Kids Broad Spectrum SPF 35 by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc., Allure Lab Inc, Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide 18.9%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses:

• Provide high protection against sunburn.
• Provide broad spectrum (UVA and UVB) protection.
• If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

Warnings: For external use only.

WHEN USING

Keep out of eyes. Rinse with water to remove.

STOP USE

Stop and ask a doctor if rash or irritation occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions:

• Apply liberally 15 minutes before sun exposure.
• Reapply: after swimming or sweating. Immediately after towel drying. At least every 2 hours.
• Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients: Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearyl Alcohol, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Isostearic Acid, Lecithin, Phenoxyethanol, Xanthan Gum, Carageenan, Helionori, Punica Granatum (Pomegranate) Extract, Plantago Lanceolate (Plantain) Leaf Extract, Ascorbyl Palmitate (Vitamin-C), Ethylhexylglycerin.

OTHER SAFETY INFORMATION

High sun protection product.

QUESTIONS

Questions? Call toll free 1-800-798-7970

PRINCIPAL DISPLAY PANEL

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

INGREDIENTS AND APPEARANCE

KIDS BROAD SPECTRUM SPF 35 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	189 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
CARRAGEENAN (UNII: 5C69YCD2YJ)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
ISOSTEARIC ACID (UNII: X33R8U0062)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4114-1	96 g in 1 TUBE; Type 0: Not a Combination Product	12/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/04/2017

Labeler - Allure Labs, LLC (926831603)

Registrant - Allure Lab, LLC (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4114)