NDC | 76159-234-01, 76159-234-02 |
Set ID | 3052af3f-8923-47bc-be6e-17396275363a |
Category | HUMAN OTC DRUG LABEL |
Packager | 3LAB, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- 3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- Keep out of reach of children.
- Directions
- Other Information
-
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 creamProduct 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. 080987545 manufacture(76159-234) Establishment Name Address ID/FEI Business Operations Englewood Lab Korea Co., Ltd. 690104005 manufacture(76159-234)