3LAB PERFECT LITE SUNSCREEN SPF 30 BROAD SPECTRUM- titanium dioxide, zinc oxide cream

3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum by

Drug Labeling and Warnings

3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by 3LAB, Inc, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum

TITANIUM DIOXIDE 2.48%
ZINC OXIDE 6.00%

Active Ingredients

TITANIUM DIOXIDE 2.48%
ZINC OXIDE 6.00%

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

Do not use on damaged or broken skin.

WHEN USING

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

STOP USE

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
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor
• Apply to all skin exposed to the sun
  

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water (Aqua/Eau), Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Polysorbate 80, Caprylyl Methicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Panthenol, Allantoin, Disodium EDTA, Lauryl PEG-9 Polydiemthylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Alumina, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin.

DESCRIPTION

PERFECT Lite Sunscreen SPF 30 Clinically proven, this advanced physical sunscreen goes on smooth, clean and light to defend the skin against harmful UV rays. Containing ingredients found in nature, it is oil, PABA and fragrance-free - ideal for all skin types including sensitive skin. Micronized Titanium Dioxide and Zinc Oxide work immediately to help prevent the harmful effects of the sun including sunburn, skin damage, freckling and discoloration. Also helps prevent heat buildup on skin. Just Perfect!

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3LAB PERFECT LITE SUNSCREEN SPF 30 BROAD SPECTRUM 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76159-234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	24.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHAMOMILE (UNII: FGL3685T2X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76159-234-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	12/19/2017
2	NDC: 76159-234-02	10 mL in 1 TUBE; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/15/2011

Labeler - 3LAB, Inc (162333277)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(76159-234)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76159-234)