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

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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 • rash occurs.

Keep out of reach of children. 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.

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

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)

6000X elemental Screen BS SPF 30 Sunscreen

6000X ELEMENTAL SCREEN BS SPF 30 SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4241
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4241-21 in 1 CARTON12/12/2023
1NDC:62742-4241-159 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/12/2023
Labeler - Allure Labs (926831603)
Registrant - Allure Labs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4241)

Revised: 12/2023
Document Id: 0c574a9a-edeb-d333-e063-6394a90a41e3
Set id: 0c574a9a-edea-d333-e063-6394a90a41e3
Version: 1
Effective Time: 20231212
 
Allure Labs