LIFECELL BROAD SPECTRUM SPF 30 MINERAL- octinoxate, zinc oxide cream 
Prime Enterprises 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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LifeCell Hydrating Antioxidant Medium BB Cream Broad Spectrum SPF 30

Active ingredients

Octinoxate 3 %

Zinc Oxide 3 %

Purpose

Sunscreen

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

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 doctor if rash occurs

Keep out of reach of children. If product

is swallowed get medical help or contact

a Posion Cotrol center right away

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

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
  • reapply:
  • after 80 minutes of 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive ingredients:

Aloe Barbadensis Leaf Juice, Bentonite, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cholecalciferol, Cyclohexasiloxane, Cyclopentasiloxane, Disodium EDTA, DMDM Hydantoin, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Isocetyl Stearate, Melanin, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sodium Chloride, Titanium Dioxide, Tocopheryl Acetate, Triethoxycaprylylsilane, Water, Iron Oxides

Other information

  • protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-866-978-5848

LifeCell Hydrating Antioxidant Medium BB Cream Broad Spectrum SPF 30 - 50 mL

Principle Display Label

LIFECELL  BROAD SPECTRUM SPF 30 MINERAL
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0426
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30.03 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30.03 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALMOND OIL (UNII: 66YXD4DKO9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
BENTONITE (UNII: A3N5ZCN45C)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CARAMEL (UNII: T9D99G2B1R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
D&C BLACK NO. 2 (UNII: 4XYU5U00C4)  
Product Characteristics
Colorbrown (Nude) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0426-350 mL in 1 BOTTLE; Type 0: Not a Combination Product10/23/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/23/2015
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0426) , manufacture(58443-0426) , label(58443-0426) , analysis(58443-0426)

Revised: 9/2021
Document Id: cc313f3a-849e-113b-e053-2995a90a8ba4
Set id: cc31402d-16ef-2926-e053-2a95a90a2115
Version: 1
Effective Time: 20210917
 
Prime Enterprises Inc.