Drug Facts

Active Ingredients:

Zinc Oxide 18.9%

Purpose

Sunscreen

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: For external use only.

Keep out of eyes. Rinse with water to remove.

Stop and ask a doctor if rash or irritation occurs.

Keep out of reach of children.

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 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.

High sun protection product.

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

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

IMGKBSSPF35

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

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

Ingredient Name	Strength
Inactive Ingredients
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
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)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/04/2017

Labeler - Allure Labs Inc. (926831603)

Registrant - Allure Lab Inc (926831603)

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