BROAD SPECTRUM SPF30 MINERAL SUNSCREEN- zinc oxide cream

Broad Spectrum SPF30 Mineral Sunscreen by

Drug Labeling and Warnings

Broad Spectrum SPF30 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Zinc Oxide (non-nano) 21 %

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

Helps prevent sunburn

If used as directed with other Sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eye Rinse with water to remove

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children If swadlowed get medical help or contact a poison control center right away

DOSAGE & ADMINISTRATION

Directions

Shake well before use

Apply generously 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending lime in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with abroad Spectrum SPF value of 15 or higher and other sun protet-Wn measures including

Limit time in the sun, especial& from 10 arn.-2 p.m

Wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months of age Ask a doctor.

OTHER SAFETY INFORMATION

Other information

'

Protect the product in this conitainer from excessive heat and direct sun

May stain some fabrics

INACTIVE INGREDIENT

Inactive Ingredients

Water (Aqua)

Caprylic/Capric Triglyceride

Coconut Alkanes

Cetearyl Alcohol

Glycerin

Coco-Glucoside

Squalane

Butyrospermum Parkii Nut Extract

Aloe Barbadensis Leaf Juice

Cetearyl Glucoside

Coco-Caprylate/Caprate

Caprylyl/Capryl Glucoside

Hydrolyzed Jojoba Esters

Cucumis Sativus (Cucumber) Fruit Extract

sr-Hydrozoan Polypeptide-1

Polyhydroxystearic Acid

Polyglyceryl-3 Polyricinoleate

Isostearic Acid

Lecithin

SodiuM Ascorbyl Phosphate

Sclerotium Gum

Xanthan Gum

Ethylhexylglycerin

Sodium Phytate

Tocopheryl Acetate

Phenoxyethanol

Sodium Benzoate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF30 MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4209
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCO GLUCOSIDE (UNII: ICS790225B)
SHEANUT (UNII: 84H6HBP32L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
CUCUMBER (UNII: YY7C30VXJT)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
PHYTATE SODIUM (UNII: 88496G1ERL)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
COCONUT ALKANES (UNII: 1E5KJY107T)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
SQUALANE (UNII: GW89575KF9)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOSTEARIC ACID (UNII: X33R8U0062)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4209-1	50 g in 1 TUBE; Type 0: Not a Combination Product	03/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2022

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4209)