6000X ELEMENTAL SCREEN BROAD SPECTRUM SPF30 SUNSCREEN- zinc oxide cream

6000X Elemental Screen Broad Spectrum SPF30 Sunscreen by

Drug Labeling and Warnings

6000X Elemental Screen Broad Spectrum SPF30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Allure Labs 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
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.

ASK DOCTOR

Stop use and ask a doctor if
rash occurs

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

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)

OTHER SAFETY INFORMATION

Other Information
Protect this product from excessive heat or direct sun

QUESTIONS

Questions or comments?
Email info@aoskincare.com
or call (415) 653-3939

PRINCIPAL DISPLAY PANEL

MANUFACTURED IN THE USA
DISTIL SKINCARE, LLC
BOX 3023, 122 15TH STREET,
DEL MAR, CA 92104, USA

INGREDIENTS AND APPEARANCE

6000X ELEMENTAL SCREEN BROAD SPECTRUM SPF30 SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4200
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)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
FERULIC ACID (UNII: AVM951ZWST)
PHORMIUM TENAX SEED OIL (UNII: OZ80CEA779)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
HONEY (UNII: Y9H1V576FH)
GARDENIA JASMINOIDES WHOLE (UNII: 0PK353KHF0)
CARRAGEENAN (UNII: 5C69YCD2YJ)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
ASTAXANTHIN (UNII: 8XPW32PR7I)
NIACINAMIDE (UNII: 25X51I8RD4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TOTAROL (UNII: 67NH2854WW)
ALMOND OIL (UNII: 66YXD4DKO9)
XANTHAN GUM (UNII: TTV12P4NEE)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOSTEARIC ACID (UNII: X33R8U0062)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHYTATE SODIUM (UNII: 88496G1ERL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4200-2	1 in 1 CARTON	02/08/2021
1	NDC: 62742-4200-1	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 final	part352	02/08/2021

Labeler - Allure Labs Inc (926831603)

Registrant - Allure Labs Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4200)