6000X ELEMENTAL SCREEN BROAD SPECTRUM SPF30 SUNSCREEN- 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 Ingredients
Zinc Oxide 18.9%

Purpose
Sunscreen

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
For external use only

Do not use
• on damaged or broken skin

When using this product
• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if
• rash occurs

If product is swallowed, get medical help or contact a Poison Control Center right away

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 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 Information
• Protect this product from excessive heat or direct sun

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

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

IMG6000XDIS

6000X ELEMENTAL SCREEN BROAD SPECTRUM SPF30 SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE189 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4200-21 in 1 CARTON02/08/2021
1NDC:62742-4200-159 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/08/2021
Labeler - Allure Labs Inc (926831603)
Registrant - Allure Labs Inc (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4200)

Revised: 2/2021
Document Id: badecf06-0fee-c308-e053-2995a90a7e7c
Set id: badecf06-0fed-c308-e053-2995a90a7e7c
Version: 1
Effective Time: 20210208
 
Allure Labs Inc