LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT- octinoxate and zinc oxide lotion
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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Active ingredients

Octinoxate 3% and 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 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 a 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-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor.

Inactive Ingrediets:

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, Hexyl Laurate, Hydrogenated Castor Oil, Iron Oxides, Isocetyl Stearate, Melanin, Octyl Stearate, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sodium Chloride, Titanium Dioxide, Tocopheryl Acetate, Water

Other information

protect this product from excessive heat and direct sun

Questions or comments? Call toll free 1-866-977-1412

PRINCIPAL DISPLAY PANEL - 30mL Bottle Label

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

cream

Hydrating Anti-Oxidant

Beauty Balm

Broad Spectrum

SPF 30

light

Sunscreen Lotion

Water Resistant (80 Minutes)

LifeCell

South Beach Skincare

1 FL OZ (30mL)

LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0182
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	29.19 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	29.19 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENTONITE (UNII: A3N5ZCN45C)
CARAMEL (UNII: T9D99G2B1R)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DMDM HYDANTOIN (UNII: BYR0546TOW)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
MELAMINE (UNII: N3GP2YSD88)
OCTYL STEARATE (UNII: 772Y4UFC8B)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALMOND OIL (UNII: 66YXD4DKO9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0182-3	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2014	09/28/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/16/2014	09/28/2022

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0182) , pack(58443-0182) , manufacture(58443-0182) , analysis(58443-0182)

Revised: 9/2022

Document Id: e9ba4a29-9aec-1d1a-e053-2995a90ad2dd

Set id: f97b6302-ab9c-40ed-add2-4f468c81ba77

Version: 4

Effective Time: 20220928

Prime Enterprises, Inc.