6000X ELEMENTAL SCREEN BS SPF 30 SUNSCREEN- zinc oxide cream

6000X Elemental Screen BS SPF 30 Sunscreen by

Drug Labeling and Warnings

6000X Elemental Screen BS SPF 30 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 18.9%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses helps to 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 eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions Apply liberally 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or sweating Children under 6 months: Ask a doctor Reapply: after swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am - 2pm wear long-sleeve shirts, pants, hats, and sunglasses.

OTHER SAFETY INFORMATION

Other information Protect this product from excessive heat or direct sun.

INACTIVE INGREDIENT

Inactive Ingredients:

Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60*, Sorbitan Stearate, Stearic Acid, Cetearyl Glucoside, Cetyl Alcohol, Astaxanthin, Niacinamide (Vitamin B3), Ferulic Acid, Tocopherol (Vitamin E), Totarol (Podocarpus Totara), Mel (Manuka Honey), Phormium Tenax (Harakeke) Seed Oil, Gardenia Jasminoides Meristem Cell Culture, Punica Granatum (Pomegranate) Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Aloe Barbadensis Leaf Juice, Carrageenan, Lecithin, Xanthan Gum, Sodium Phytate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Dehydroacetic Acid, Stearyl Alcohol, Benzyl Alcohol. *Tween 60-LQ(AP)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

6000X ELEMENTAL SCREEN BS SPF 30 SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)
ALMOND OIL (UNII: 66YXD4DKO9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHYTATE SODIUM (UNII: 88496G1ERL)
ISOSTEARIC ACID (UNII: X33R8U0062)
CETYL ALCOHOL (UNII: 936JST6JCN)
NIACINAMIDE (UNII: 25X51I8RD4)
TOTAROL (UNII: 67NH2854WW)
PHORMIUM TENAX SEED OIL (UNII: OZ80CEA779)
CARRAGEENAN (UNII: 5C69YCD2YJ)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GLYCERIN (UNII: PDC6A3C0OX)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
FERULIC ACID (UNII: AVM951ZWST)
TOCOPHEROL (UNII: R0ZB2556P8)
HONEY (UNII: Y9H1V576FH)
STEARIC ACID (UNII: 4ELV7Z65AP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ASTAXANTHIN (UNII: 8XPW32PR7I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4241-2	1 in 1 CARTON	12/12/2023
1	NDC: 62742-4241-1	59 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/12/2023

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4241)