Broad Spectrum SPF 35 ECO by Allure Labs Inc / Allure Labs Inc. Drug Facts

Broad Spectrum SPF 35 ECO by

Drug Labeling and Warnings

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

Drug Details [pdf]

BROAD SPECTRUM SPF 35 ECO- zinc oxide cream 
Allure Labs Inc

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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Drug Facts

Active Ingredient:

Zinc Oxide - 18.9%

Purpose: Sunscreen

Warnings: For external use only.

When using this product:

• 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 Ingrediaents: 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, Xanthan Gum, Carageenan, Helionori, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Tocopherol, Ethylhexylglycerin.

High sun protection product.

Call toll free 1-800-798-7970

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

BROAD SPECTRUM SPF 35 ECO 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4115
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
WATER (UNII: 059QF0KO0R)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
TOCOPHEROL (UNII: R0ZB2556P8)
CARRAGEENAN (UNII: 5C69YCD2YJ)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4115-1	85 g in 1 TUBE; Type 0: Not a Combination Product	06/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/12/2018

Labeler - Allure Labs Inc (926831603)

Registrant - Allure Labs Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs Inc.		926831603	manufacture(62742-4115)

Revised: 1/2021

Document Id: b86e82bf-7c85-6fbe-e053-2995a90ae1a3

34390-5

Set id: b86e82bf-7c84-6fbe-e053-2995a90ae1a3

Version: 1

Effective Time: 20210108